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 .
Status of Application
This action is in reply to the correspondence received September 3, 2025 (hereinafter “Reply”).
Claims 1, 3, 5, 7, and 20 are amended.
Claims 1-20 are pending.
Claim Rejections - 35 U.S.C. § 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103 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.
Claims 1-4, 6-15, and 17-19 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Waugh et al. (U.S. Pub. No. 2010/0268380 A1) in view of Bertone (U.S. Pub. No. 2018/0184682 A1).
Claim 1: Waugh, as shown, discloses the following limitations:
an enclosure defining a controlled access space (see at least ¶ [0019]: The drug vault may be configured for secure storage of the medicaments, and be connected to the user-interface module, with the user-interface forming a front end of the apparatus and the drug vault forming a back end of the apparatus; see also at least ¶ [0025]: the user-interface module is preferably configured for staged security level access by a human operator whereby a first level security access is restricted to access pre-selected components of the front end user-interface module only and a second level security access includes access according to the first level security access and access to the control system and the drug vault module including the inventory thereof; see also at least ¶¶ [0035] and [0090]);
a prescription filling unit disposed within the controlled access space, the prescription filling unit configured to package and label a patient prescription of medication obtained from medication storage within the prescription filling unit (see at least ¶ [0013]: there is provided apparatus for delivering medicaments to users, the apparatus comprising a drug vault having a pre-packaged product storage container for containing pre-packaged medicament product, a bulk product storage container for containing bulk form medicament, and a control system operable to effect at least a part of a process to dispense bulk form medicament from the bulk product storage container, to pack as a dispensed packaged medicament product the dispensed bulk form medicament, and to pick and deliver medicament products to a delivery zone. Preferably, at least a part of the control system is commonly deployed in handling both the pre-packaged medicament products and the dispensed packaged medicament products whereby to limit the volume and footprint of the apparatus; see also at least ¶ [0020]: the apparatus may further comprise a product labeling module configured for storing a stock of labels and for labeling a medicament product to be dispensed by the apparatus, the product labeling module operable to suspend a label from the stock of labels, and having an applicator for applying the label to the medicament product, the control system operable to transport the medicament product to the suspended label, and to align a front edge of the label with a pre-determined contact start point on the medicament product; see also at least ¶ [0038]: FIGS. 8A-B illustrate an example of a packaging module of the automated apparatus of the invention, for packaging drugs to be dispensed to a user in bottles or foil packs, wherein FIG. 8A is a perspective view and FIG. 8B is a front view thereof; see also at least ¶ [0039]: FIGS. 9A-9B illustrate an example of a drug storage module of the automated apparatus of the invention, showing multiple, standard slots for housing bulk storage cassettes therein, and an exemplary bulk storage cassette in one such slot, for retrieval by a robot of the apparatus and transfer to a packaging module, wherein FIG. 9A is a perspective view thereof and FIG. 9B is a detail view to a larger scale of portion A of FIG. 9A; see also at least ¶¶ [0014]-[0016] and [0109]);
a finished prescription unit disposed within the controlled access space and coupled to the prescription filling unit, the finished prescription unit configured to store the packaged and labeled patient prescription obtained from the prescription filling unit (see at least ¶ [0013] and the analysis above; see also at least ¶ [0018]: the apparatus further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone. The apparatus may further comprise a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system; see also at least ¶ [0104]: the control system also includes a cap pick and placement module. Following the dispensing of the desired number of pills into the bottle as previously described, the cap pick and placement module places a selected cap on the on the open neck of the bottle and a levering mechanism applies downward pressure on the cap to snap it over the neck. The control system is then driven to deliver the bottle containing the dispensed pills to a delivery zone accessible by the kiosk user);
an interface kiosk coupled to the enclosure and disposed adjacent the finished prescription unit, the interface kiosk configured to receive input from a user and to dispense a finished prescription obtained from the finished prescription unit to the user (see also at least ¶ [0018] and the analysis above; see also at least ¶ [0019]: the drug vault may be configured for secure storage of the medicaments, and be connected to the user-interface module, with the user-interface forming a front end of the apparatus and the drug vault forming a back end of the apparatus; see also at least ¶ [0104]: the control system also includes a cap pick and placement module. Following the dispensing of the desired number of pills into the bottle as previously described, the cap pick and placement module places a selected cap on the on the open neck of the bottle and a levering mechanism applies downward pressure on the cap to snap it over the neck. The control system is then driven to deliver the bottle containing the dispensed pills to a delivery zone accessible by the kiosk user);
a third utility connection to an electric power line to deliver power into the enclosure to at least one of the prescription filling unit, the finished prescription unit, or the interface kiosk (see at least ¶ [0091]: in the event that a network connection cannot be established by the apparatus due to network interruption or prolonged power failure beyond the hold up time of an internal UPS, a controlled access key can be used for access to the level one interior space to restore power or network connectivity. Access to the level two controlled regions of the apparatus, such as the drug vault module, can only be achieved with network confirmation);
an image capture device configured to capture photographs from within the enclosure for remote inspection by the pharmacist (see at least ¶ [0067]: as shown in FIG. 4, several networked video cameras 150 are installed inside the apparatus 10 to view what is taking place in the apparatus, and this visual information is used by the control system 100 as well as remotely, if needed, by a human agent; see also at least ¶¶ [0087] and [0091]).
Waugh does not explicitly disclose, but Bertone, as shown, teaches the following limitations:
a first utility connection to a water supply to deliver water inside the enclosure (see at least ¶ [0162]: the fresh water line 282 can be connected to the water heater 284, the water outlet 288, and the ice maker 39 if provided. However, if the ice maker 39 is connected to its own dedicated water supply, this supply may be identical to the fresh water line 282; see also at least ¶¶ [0148]: to this end, the beverage production apparatus 10 comprises the water dispensing unit 28 to provide water for the production of beverages, as well as for other operations (e.g., sanitation and ice jam clearance));
a second utility connection to a sewer line to deliver waste out of the enclosure (see at least ¶ [0271]: the waste egress system 55 is used after sanitizing operations are complete and empties the sanitizing solution and associated waste material from the sanitizing chamber 49 to the drain that is generally used to dispose of waste water. The egress system 55 is comprised of a sanitizing chamber waste drain line 71, a waste drain pinch mechanism 73, and a sanitizing chamber waste drain 75 that is connected to the drainage system for the beverage production apparatus 10 (not shown) in order to dispose of the waste materials in the general waste water/sewage system; see also at least ¶ [0055]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the water supply and drain connections taught by Bertone with the prescription dispensing systems disclosed by Waugh, because Bertone teaches at ¶¶ [0251] and [0271] that these features can be used to allow sanitizing operations to occur to prevent cross-contamination. See M.P.E.P. § 2143(I)(G).
Moreover, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the water supply and drain connections taught by Bertone with the prescription dispensing systems disclosed by Waugh, because the claimed invention is merely a combination of old elements (the water supply and drain connections taught by Bertone and the prescription dispensing systems disclosed by Waugh), in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. See M.P.E.P. § 2143(I)(A).
Claim 2: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the prescription filling unit comprises a manipulation device (see at least ¶ [0017]: the apparatus may further including a treatment mechanism operable to alter the bulk form medicament from an inventory state to a dispensing state prior to the bulk form medicament being dispensed and packaged as the dispensed packaged medicament product. For example, the treatment mechanism can be operable to effect at least one of mixing, reconstituting, agitating and diluting of the bulk form medicament; see also at least ¶¶ [0057]-[0059] and [0108]).
Claim 3: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the prescription filling unit comprises a medication storage and retrieval system configured to store bulk quantities of a plurality of medications within a plurality of containers (see at least ¶ [0014]: the control system includes a medicament packaging module operable to dispense and package the bulk form medicament as a dispensed packaged medicament product that is one of a bottle, a box and a foil package. The apparatus can further comprise a metering module operable to meter a selected amount of the bulk form medicament and to deliver the selected amount from the bulk product storage container; see also at least ¶¶ [0015]-[0016]) and
wherein the image capture device is configured to photo inspect a strip of sequential pouches filled with medications by the manipulation unit (see at least ¶ [0067]: as shown in FIG. 4, several networked video cameras 150 are installed inside the apparatus 10 to view what is taking place in the apparatus, and this visual information is used by the control system 100 as well as remotely, if needed, by a human agent; see also at least ¶ [0121]: a back end drug vault module 200 of the apparatus 10 has a fixed number of storage slots 207 for product. As shown by FIGS. 15A-d, each storage slot 207 can store up to five units of the same product SKU—i.e., in a strip; see also at least ¶ [0108]: the medication packaging module 280 can load medication into sterile foil seal pouches, apply a foil seal and verify seal via visual inspection; see also at least ¶¶ [0087] and [0091]).
Claim 4: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the plurality of containers includes one or more of bulk solid drug portion containers, bulk liquid containers, bulk containers of individual ointment tubes and bulk powder containers (see at least ¶ [0015]: the medicament product can be stored in bulk form as individually dispensable items, with the metering module operable to meter the selected amount of the bulk form medicament as a metered plurality of individually dispensable items. The metering mechanism can further include a singulator successively to take items of the individually dispensable items and to deliver the taken items for packing, and a counter to count the number of items taken from the individually dispensable items and delivered for packing. Typically, the individually dispensable items are one or more of pills, lozenges and capsules; see also at least ¶ [0016]: the bulk form medicament may alternatively or additionally be stored in a bulk product storage container as a liquid. With such an arrangement, an alternative or additional metering mechanism is included that is operable to meter the bulk form medicament as a metered volume of the liquid. For certain liquid medicaments, the bulk storage container can be within a refrigerated zone, whereby liquid medicament stored therein is maintained at a lowered temperature to prevent heat-induced deterioration thereto).
Claim 6: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the prescription filling unit comprises a pill counting and packaging station configured to:
count and confirm an appropriate number of solid drug portions to fill the patient prescription (see at least ¶ [0014]: the control system includes a medicament packaging module operable to dispense and package the bulk form medicament as a dispensed packaged medicament product that is one of a bottle, a box and a foil package. The apparatus can further comprise a metering module operable to meter a selected amount of the bulk form medicament and to deliver the selected amount from the bulk product storage container; see also at least ¶¶ [0015]-[0016], 0037], [0054]-[0055], [0094]-[0097], and [0100]); and
package the appropriate number of solid drug portions into a prescription container (see at least ¶ [0014]: the control system includes a medicament packaging module operable to dispense and package the bulk form medicament as a dispensed packaged medicament product that is one of a bottle, a box and a foil package. The apparatus can further comprise a metering module operable to meter a selected amount of the bulk form medicament and to deliver the selected amount from the bulk product storage container; see also at least ¶¶ [0015]-[0016], [0037], [0054]-[0055], [0094]-[0097], and [0100]).
Claim 7: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the pill counting and packaging station comprises a manipulation device (see at least ¶ [0017]: the apparatus may further including a treatment mechanism operable to alter the bulk form medicament from an inventory state to a dispensing state prior to the bulk form medicament being dispensed and packaged as the dispensed packaged medicament product. For example, the treatment mechanism can be operable to effect at least one of mixing, reconstituting, agitating and diluting of the bulk form medicament; see also at least ¶¶ [0015]-[0016], [0037], [0054]-[0055], [0057]-[0059], [0094]-[0097], [0100], and [0108]).
Waugh does not explicitly disclose, but Bertone, as shown, teaches the following limitations:
the manipulation device comprising a self-cleaning component to prevent cross-contamination between medications handled by the manipulation device (see at least ¶ [0364]: the control unit 16 sends a sequence of signals to the sanitizing unit 37 (as well as a second set of signal to the mixer unit 14) in order to perform cleaning operations that sanitize the mixer 142; see also at least ¶¶ [0059] and [0253]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the self-cleaning techniques taught by Bertone with the prescription dispensing systems disclosed by Waugh, because Bertone teaches at ¶ [0253] that “it may be useful to prevent both flavor cross-contamination as well as bacterial contamination from the mixer 142 to maximize customer satisfaction, protect operator revenue and ensure public safety. While the materials used in the construction of the mixer shaft 148 and the mixing blade(s) 1410 may provide some assistance in the prevention of both types of contamination, a better solution would be to clean these components on a regular basis (e.g., between beverages) to remove both flavor residue and bacterial contaminants.” See M.P.E.P. § 2143(I)(G).
Moreover, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the self-cleaning techniques taught by Bertone with the prescription dispensing systems disclosed by Waugh, because the claimed invention is merely a combination of old elements (the self-cleaning techniques taught by Bertone and the prescription dispensing systems disclosed by Waugh), in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. See M.P.E.P. § 2143(I)(A).
Claim 8: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the prescription filling unit comprises a liquid filling station configured to:
measure and confirm an appropriate volume of liquid medication to fill the patient prescription (see at least ¶ [0016]: the bulk form medicament may alternatively or additionally be stored in a bulk product storage container as a liquid. With such an arrangement, an alternative or additional metering mechanism is included that is operable to meter the bulk form medicament as a metered volume of the liquid. For certain liquid medicaments, the bulk storage container can be within a refrigerated zone, whereby liquid medicament stored therein is maintained at a lowered temperature to prevent heat-induced deterioration thereof; see also at least ¶ [0108]: the dispensary apparatus 10 of the invention provides a bulk storage container for liquid product 220 with an integrated pouring unit 226 as shown by FIGS. 25A-B. This bulk liquid medication container 220 is operated by the robot to pour a measured amount of medication into liquid dispensing containers (not shown). Some medications require reconstitution generally with another liquid prior to dispensing. A reconstitution bulk storage container 370 is shown in FIGS. 26A-C and includes a mixer/agitator 32 and a liquid/concentrate storage section 34 for adding liquids to concentrates and pass them to a mixing cell for stirring or agitation. Similarly, some medications require mixing of two or more components prior to dispensing. A mixing bulk storage container 380 is shown by FIGS. 27A-B. The mixing container 380 includes liquid storage sections 382, a mixer 384 and mixing valves and piping 386 for measuring and dispensing mixed medication to a liquid dispensing container according to any number and amount of liquid components by weight, volume or percentage. Further, some medications require geometric reduction of one or more components in a carrier. A compounding bulk storage container 390 is shown in FIGS. 28A-B and includes liquid storage sections 391, a mixer 394 and mixing valves and piping 396 for performing geometric reduction of one or more components in a carrier; see also at least ¶¶ [0056]-[0057]);
package the liquid medication into a prescription container (see at least ¶¶ [0016], [0056]-[0057], and [0108] and the analysis above); and
transfer waste from filling the patient prescription […] (see at least ¶ [0072]: the control system 100 is also controlled to do anything in its power to get unstuck, so it doesn't jam (since the apparatus is unattended). The primary rule applied by the robot is that it must not jam. For the robot, to not a make an error is a lesser rule (having lower priority) because the robot has access to a waste container 115 and a waste arm 110 which it uses to direct damaged product. If the control system 100 detects an error it transfers the product to the waste container; see also at least ¶¶ [0033] and [0078]).
Waugh does not explicitly disclose, but Bertone, as shown, teaches the following limitations:
receive water via the first utility connection (see at least ¶ [0162]: the fresh water line 282 can be connected to the water heater 284, the water outlet 288, and the ice maker 39 if provided. However, if the ice maker 39 is connected to its own dedicated water supply, this supply may be identical to the fresh water line 282; see also at least ¶¶ [0148]: to this end, the beverage production apparatus 10 comprises the water dispensing unit 28 to provide water for the production of beverages, as well as for other operations (e.g., sanitation and ice jam clearance));
[transfer waste] to the second utility connection (see at least ¶ [0271]: the waste egress system 55 is used after sanitizing operations are complete and empties the sanitizing solution and associated waste material from the sanitizing chamber 49 to the drain that is generally used to dispose of waste water. The egress system 55 is comprised of a sanitizing chamber waste drain line 71, a waste drain pinch mechanism 73, and a sanitizing chamber waste drain 75 that is connected to the drainage system for the beverage production apparatus 10 (not shown) in order to dispose of the waste materials in the general waste water/sewage system; see also at least ¶ [0055]).
The rationales to modify/combine the teachings of Waugh to include the teachings of Bertone are presented above regarding claim 1 and incorporated herein.
Claim 9: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the liquid filling station comprises a manipulation device (see at least ¶ [0016]: the bulk form medicament may alternatively or additionally be stored in a bulk product storage container as a liquid. With such an arrangement, an alternative or additional metering mechanism is included that is operable to meter the bulk form medicament as a metered volume of the liquid. For certain liquid medicaments, the bulk storage container can be within a refrigerated zone, whereby liquid medicament stored therein is maintained at a lowered temperature to prevent heat-induced deterioration thereof; see also at least ¶ [0108]: the dispensary apparatus 10 of the invention provides a bulk storage container for liquid product 220 with an integrated pouring unit 226 as shown by FIGS. 25A-B. This bulk liquid medication container 220 is operated by the robot to pour a measured amount of medication into liquid dispensing containers (not shown). Some medications require reconstitution generally with another liquid prior to dispensing. A reconstitution bulk storage container 370 is shown in FIGS. 26A-C and includes a mixer/agitator 32 and a liquid/concentrate storage section 34 for adding liquids to concentrates and pass them to a mixing cell for stirring or agitation. Similarly, some medications require mixing of two or more components prior to dispensing. A mixing bulk storage container 380 is shown by FIGS. 27A-B. The mixing container 380 includes liquid storage sections 382, a mixer 384 and mixing valves and piping 386 for measuring and dispensing mixed medication to a liquid dispensing container according to any number and amount of liquid components by weight, volume or percentage. Further, some medications require geometric reduction of one or more components in a carrier. A compounding bulk storage container 390 is shown in FIGS. 28A-B and includes liquid storage sections 391, a mixer 394 and mixing valves and piping 396 for performing geometric reduction of one or more components in a carrier; see also at least ¶¶ [0056]-[0057]).
Claim 10: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the prescription filling unit comprises a labeling and packaging station configured to print and affix a label to a filled prescription container (see at least ¶ [0020]: the apparatus may further comprise a product labeling module configured for storing a stock of labels and for labeling a medicament product to be dispensed by the apparatus, the product labeling module operable to suspend a label from the stock of labels, and having an applicator for applying the label to the medicament product, the control system operable to transport the medicament product to the suspended label, and to align a front edge of the label with a pre-determined contact start point on the medicament product; see also at least ¶ [0109]: each package has to be labelled. It would be of value to have a labelling apparatus and method, which are versatile in the sense of being applicable to such a range of package shapes and sizes. For medicament dispensing kiosks, medicament package labels are typically of a standard shape and size to enable them to be passed through a printer, and must contain critical patient and medication information in conformance with industry standards and offering little scope for variation in shape, size or materials. Such labels are typically applied by running pressure sensitive adhesive back coated labels on a peal-away carrier through a label printer and transferring the printed label to the medicament container such as a bottle or box. Known label transfer methods have used sponges, vacuum, sponges and vacuum in combination, transfer media, transfer roller and pressure pads. There is a need for reliable accurate placement and adhesion of standard flat labels to dispensed medicament products; see also at least ¶¶ [0110]-[0120]).
Claim 11: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the labeling and packaging station is configured to package the filled prescription container in a final prescription package (see at least ¶ [0020]: the apparatus may further comprise a product labeling module configured for storing a stock of labels and for labeling a medicament product to be dispensed by the apparatus, the product labeling module operable to suspend a label from the stock of labels, and having an applicator for applying the label to the medicament product, the control system operable to transport the medicament product to the suspended label, and to align a front edge of the label with a pre-determined contact start point on the medicament product; see also at least ¶ [0109]: each package has to be labelled. It would be of value to have a labelling apparatus and method, which are versatile in the sense of being applicable to such a range of package shapes and sizes. For medicament dispensing kiosks, medicament package labels are typically of a standard shape and size to enable them to be passed through a printer, and must contain critical patient and medication information in conformance with industry standards and offering little scope for variation in shape, size or materials. Such labels are typically applied by running pressure sensitive adhesive back coated labels on a peal-away carrier through a label printer and transferring the printed label to the medicament container such as a bottle or box. Known label transfer methods have used sponges, vacuum, sponges and vacuum in combination, transfer media, transfer roller and pressure pads. There is a need for reliable accurate placement and adhesion of standard flat labels to dispensed medicament products; see also at least ¶¶ [0110]-[0120]).
Claim 12: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the labeling and packaging station is configured to print and affix prescription instructions to the final prescription package (see at least ¶ [0020]: the apparatus may further comprise a product labeling module configured for storing a stock of labels and for labeling a medicament product to be dispensed by the apparatus, the product labeling module operable to suspend a label from the stock of labels, and having an applicator for applying the label to the medicament product, the control system operable to transport the medicament product to the suspended label, and to align a front edge of the label with a pre-determined contact start point on the medicament product; see also at least ¶ [0109]: each package has to be labelled. It would be of value to have a labelling apparatus and method, which are versatile in the sense of being applicable to such a range of package shapes and sizes. For medicament dispensing kiosks, medicament package labels are typically of a standard shape and size to enable them to be passed through a printer, and must contain critical patient and medication information in conformance with industry standards and offering little scope for variation in shape, size or materials. Such labels are typically applied by running pressure sensitive adhesive back coated labels on a peal-away carrier through a label printer and transferring the printed label to the medicament container such as a bottle or box. Known label transfer methods have used sponges, vacuum, sponges and vacuum in combination, transfer media, transfer roller and pressure pads. There is a need for reliable accurate placement and adhesion of standard flat labels to dispensed medicament products; see also at least ¶¶ [0110]-[0120]).
Claim 13: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the labeling and packaging station comprises a manipulation device (see at least ¶ [0020]: the apparatus may further comprise a product labeling module configured for storing a stock of labels and for labeling a medicament product to be dispensed by the apparatus, the product labeling module operable to suspend a label from the stock of labels, and having an applicator for applying the label to the medicament product, the control system operable to transport the medicament product to the suspended label, and to align a front edge of the label with a pre-determined contact start point on the medicament product; see also at least ¶ [0109]: each package has to be labelled. It would be of value to have a labelling apparatus and method, which are versatile in the sense of being applicable to such a range of package shapes and sizes. For medicament dispensing kiosks, medicament package labels are typically of a standard shape and size to enable them to be passed through a printer, and must contain critical patient and medication information in conformance with industry standards and offering little scope for variation in shape, size or materials. Such labels are typically applied by running pressure sensitive adhesive back coated labels on a peal-away carrier through a label printer and transferring the printed label to the medicament container such as a bottle or box. Known label transfer methods have used sponges, vacuum, sponges and vacuum in combination, transfer media, transfer roller and pressure pads. There is a need for reliable accurate placement and adhesion of standard flat labels to dispensed medicament products; see also at least ¶¶ [0110]-[0120]).
Claim 14: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the finished prescription unit comprises:
a storage system configured to receive and hold a plurality of final prescription packages received from the prescription filling unit (see at least ¶ [0121]: if the product is available, the first apparatus requests a secure transfer of the medication. The robot of the second apparatus is instructed to carry out a product pick, scan and verification that the product is correct, then deliver it to a left or right side secure transfer slot of the apparatus (not shown). The robot of the first apparatus travels to a right or left side secure transfer slot of that apparatus and, when in correct position, a transfer order handshake is exchanged between the first and second apparatus, allowing the transfer ports to open and the requested product to be passed from a platen of the robot of the second apparatus to a receiving platen of the robot of the first apparatus. After the transfer is complete, the second apparatus retracts its robot platen, verifies that the transfer was completed and closes its transfer door. The robot of the first apparatus verifies the product received, confirms identity of the product against the drug record, and continues the dispense cycle in the same manner as if the drug had been located within the drug vault module of the first apparatus; see also at least ¶¶ [0023], [0060], [0067], [0074], [0087], and [0091]); and
one of a scanner and an imaging device (see at least ¶¶ [0023], [0060], [0067], [0074], [0087], [0091], and [0121] and the analysis above; see also at least ¶¶ [0005]).
Claim 15: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the finished prescription unit comprises a manipulation device (see at least ¶ [0020]: the apparatus may further comprise a product labeling module configured for storing a stock of labels and for labeling a medicament product to be dispensed by the apparatus, the product labeling module operable to suspend a label from the stock of labels, and having an applicator for applying the label to the medicament product, the control system operable to transport the medicament product to the suspended label, and to align a front edge of the label with a pre-determined contact start point on the medicament product; see also at least ¶ [0109]: each package has to be labelled. It would be of value to have a labelling apparatus and method, which are versatile in the sense of being applicable to such a range of package shapes and sizes. For medicament dispensing kiosks, medicament package labels are typically of a standard shape and size to enable them to be passed through a printer, and must contain critical patient and medication information in conformance with industry standards and offering little scope for variation in shape, size or materials. Such labels are typically applied by running pressure sensitive adhesive back coated labels on a peal-away carrier through a label printer and transferring the printed label to the medicament container such as a bottle or box. Known label transfer methods have used sponges, vacuum, sponges and vacuum in combination, transfer media, transfer roller and pressure pads. There is a need for reliable accurate placement and adhesion of standard flat labels to dispensed medicament products; see also at least ¶¶ [0110]-[0120]).
Claim 17: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the interface kiosk comprises:
a display configured to provide visual information to the user (see at least ¶ [0018]: the apparatus further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone. The apparatus may further comprise a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system);
an audio device configured to one of provide audio information to the user and receive audio input from the user (see at least ¶ [0018]: the apparatus further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone. The apparatus may further comprise a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system; see also at least ¶ [0005]: a user interface, a teleconferencing or video-conferencing means enabling communication between the user and a human validation agent, and a scanning means for capturing an image of the script so that it, if needed, it can be viewed by a human validation agent, such as a licensed pharmacist communicating in the system and with the apparatus from a remote location to the apparatus, to approve a prescription);
a communication interface configured to provide an audiovisual connection to a remote pharmacist via an audiovisual device (see at least ¶ [0018]: the apparatus further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone. The apparatus may further comprise a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system; see also at least ¶ [0005]: a user interface, a teleconferencing or video-conferencing means enabling communication between the user and a human validation agent, and a scanning means for capturing an image of the script so that it, if needed, it can be viewed by a human validation agent, such as a licensed pharmacist communicating in the system and with the apparatus from a remote location to the apparatus, to approve a prescription);
an input device configured to receive information entered by the user (see at least ¶ [0018]: the apparatus further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone. The apparatus may further comprise a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system;);
a scanning device configured to read information from a user provided medium (see at least ¶ [0018]: the apparatus further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone. The apparatus may further comprise a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system; see also at least ¶ [0100]); and
a delivery device configured to provide user access to the finished prescription (see at least ¶ [0018]: the apparatus further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone. The apparatus may further comprise a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system).
Claim 18: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the interface kiosk is configured as one of a drive-up kiosk and a walk-up kiosk (see at least ¶ [0031]: FIG. 1 illustrates a front view of an embodiment of the automated apparatus for dispensing medicaments in accordance with the invention, wherein two, side-by-side front end user-interface modules are shown; see also at least ¶ [0035] and FIGS. 5A-B).
Claim 19: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
a utility connection to one or more of a communication line and a heating/cooling duct (see at least ¶ [0018]: the apparatus further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone. The apparatus may further comprise a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system; see also at least ¶ [0049]: FIG. 19A illustrates a front view of an example of a refrigerated storage module of the automated apparatus of the invention with cooling device, insulated sliding door, locking unit and air purge means provided by a dehumidifier and pressure control unit, and FIG. 19B illustrates a perspective view of this exemplary module).
Claims 5 and 20 rejected under AIA 35 U.S.C. § 103 as being unpatentable over Waugh et al. (U.S. Pub. No. 2010/0268380 A1) in view of Bertone (U.S. Pub. No. 2018/0184682 A1) and further in view of Ma et al. (CN 204015615 U) (hereinafter “Ma”).
Claim 5: The combination of Waugh and Bertone teaches the limitations as shown in the rejections above. Further, Waugh, as shown, discloses the following limitations:
wherein the medication storage and retrieval system comprises a manipulation device (see at least ¶ [0017]: the apparatus may further including a treatment mechanism operable to alter the bulk form medicament from an inventory state to a dispensing state prior to the bulk form medicament being dispensed and packaged as the dispensed packaged medicament product. For example, the treatment mechanism can be operable to effect at least one of mixing, reconstituting, agitating and diluting of the bulk form medicament; see also at least ¶¶ [0057]-[0059] and [0108]); and
a data capture device configured to provide temperature […] data for a retrieved item for remote inspection by a pharmacist (see at least ¶ [0093]: the apparatus also contains monitoring sensors (not shown) within the storage areas to sense internal temperature for the purposes of control of temperature, as well as to monitor temperature to report to a log file for correct temperature storage verification for a drug pedigree file and to report any temperature fluctuations in the form of high or low temperature alarms to the network for remedial action. Any drug that has been exposed to a temperature, or time and temperature beyond its allowable range is tagged to identify this via a drug pedigree established by the system and is removed from accessible inventory for disposal).
Waugh does not explicitly disclose, but Ma, as shown, teaches the following limitations:
provide humidity data (see at least ¶ [0007]: preferably, the constant humidity device comprises a humidity sensor, a humidity controller and a humidifier connected in turn, the humidity controller receiving humidity sensor measures for humidity information, and control the humidity in the humidifying regulating cabinet main body in; see also at least ¶ [0020]: said intelligent distribution cabinet further comprises device 80, can better guarantee the humidity of the dispensing cabinet in the constant humidity device 80 comprises a humidity sensor, a humidity controller and a humidifier connected in turn, the humidity controller receiving humidity sensor for humidity information measurement and control adjusting cabinet body of the humidifier of humidity in 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the humidity monitoring techniques taught by Ma with the prescription dispensing systems disclosed by Waugh (as modified by Bertone), because Ma teaches at ¶ [0020] that this information is used to “control adjusting cabinet body of the humidifier of humidity” and at ¶ [0012] that by using its techniques, a medicine cabinet “can better store medicine.” See M.P.E.P. § 2143(I)(G).
Moreover, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the humidity monitoring techniques taught by Ma with the prescription dispensing systems disclosed by Waugh (as modified by Bertone), because the claimed invention is merely a combination of old elements (the humidity monitoring techniques taught by Ma, the water supply and drain connections taught by Bertone, and the prescription dispensing systems disclosed by Waugh), in the combination each element merely would have performed the same f