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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 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.
Claim(s) 1, 3, 5-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over van den Brink (US 2017/0016836) (Brink) in view of Archer et al (US 5,522,512) (Archer).
Regarding claim 1, Brink discloses a drug inspection apparatus that inspects dispensed drugs (abstract), comprising:
a pre-inspection storage portion that temporarily stores a drug group which is a plurality of drugs collectively charged (par [0027][0031]);
an inspection imaging portion that takes images of individual drugs of the drug group on the conveyance path (par [0028][0052][0073]);
a discharge processing portion that discharges the imaged drug group to a post-inspection storage portion (par [0011][0030][0075][0076][0077]);
the post-inspection storage portion that temporarily stores the drug group discharged by the discharge processing portion, and then discharges the drug group to the outside of the apparatus (par [0011][0075][0076][0077]); and
an inspection control portion that executes, by software control, a control of operations of the pre-inspection storage portion, the transfer processing portion, the conveyance inspection processing portion (par [0029][0074]), the discharge processing portion and the post-inspection storage portion (par [0030]), and an inspection process for the drug group, which uses a captured image by the inspection imaging portion (par [0074]), wherein
the inspection control portion performs image identification of the captured image of the drug group by the inspection imaging portion with the use of master data of a plurality of types of drugs that have been registered in advance (par [0074]), in the inspection process for the drug group, thereby identifies the type and the number of the imaged individual drugs, inspects whether or not the identified content matches the constitution of the drugs shown in the prescription data of the drug group, and notifies an inspection result (par [0074]).
Brink does not expressly teach that the pre-inspection storage portion spreads the individual drugs in an elongated and substantially one row, or that the drug group is transferred to and conveyed along a conveyance path at a predetermined speed while maintaining that spread state.
However, Archer teaches these features. Archer teaches a system for automatically feeding, inspecting, and diverting tablets, including a tablet conveyor system that divides tablets into a plurality of tablet streams for inspection by color, size, and shape, and teaches that the entire system is computer controlled by various control mechanisms to enable operation without operator assistance (Abstract). Archer teaches that the tablet hopper feeds a vibratory feeder, and that “the vibratory feeder 17 produces well defined and singulated streams of tablets 21” (col. 5). Archer further teaches that the vibratory trackway linear speed can be varied automatically for different tablets by adjusting the vibration amplitude of the vibratory drive, and that the tablet streams are fed to a conveyor system that transports the streams of tablets to an inspection system for sorting prior to filling (col. 5). Archer also teaches that the conveyor belt typically runs at a speed of 200 mm/sec (col. 6). Thus, Archer teaches spreading/arranging tablets into well-defined singulated streams, i.e., elongated substantially one-row streams, transferring the tablets to a conveyor path, and conveying the tablets at a predetermined speed for imaging/inspection.
Archer also teaches that the inspection system inspects streams of tablets as they pass on the belt to check whether the tablets are of the correct color, shape, and size and whether they are undamaged (col. 6). Archer teaches that the inspection system uses line scan cameras and image processing hardware to extract edge and color information, and that the processed inspection results are sent to a diverter control for tablet diversion (cols. 6-7). Archer further teaches software/computer control of the tablet conveyor, vibratory feeder, inspection systems, and diverter mechanisms through a distributed control system, including a filling station control, tablet conveyor system control, diverter control, and bottle conveyor system control (cols. 11-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify van den Brink’s receiving/checking device to incorporate Archer’s vibratory feeder/conveyor arrangement that produces well-defined singulated tablet streams and conveys the tablets at a predetermined speed to an inspection system. The motivation would have been to reduce tablet overlap and improve the reliability and speed of optical recognition of individual pills in a dose. Brink itself recognizes that pills may be stacked or overlapping and teaches using a shaker to separate pills when they are not clear of each other (par [0052], [0074]). Archer provides a known solution in the same field of automated pharmaceutical inspection by using a vibratory feeder to produce well-defined singulated tablet streams and a conveyor to transport those streams past an inspection system at a controlled speed. Applying Archer’s singulating conveyor to Brink would have predictably improved Brink’s automated dose-checking apparatus by presenting the pills in a more separated, orderly, and imageable arrangement, thereby improving inspection accuracy and throughput.
Therefore, the combination of Brink and Archer teaches or suggests all limitations of claim 1, and claim 1 would have been obvious.
Regarding claim 3, Brink teaches that the apparatus is used for sequentially processing individualized compound doses of medicines, because Brink teaches “for each of a series of subsequent intake moments, pills are collected from selected cassettes of a dispensing machine to form an individualized compound dose of medicine in accordance with a patient prescription record.” (par [0070]). Brink also teaches repeating the steps of receiving a plurality of dispensed medicines forming an individualized compound dose (par [0023]), assessing the composition of the dose, checking the assessed composition against a record, and discharging the dose depending on whether the check is positive or negative (par [0027]-[0031]).
Regarding the limitation that the conveyance inspection processing portion has a section structure capable of dividing the drug groups continuously charged into a predetermined number in a charged order and conveying the drug groups, Brink teaches that the device may comprise a number of transport receptacles arranged to receive a dose from the dose buffer and confine the dose in the receptacle during transport (par [0033]). Brink further teaches that the transport receptacles are arranged to transport the dose from an assessment area to a discharge area and that the receptacles are indexable (par [0033]). The claimed “section structure” is interpreted broadly as a structure having a plurality of sections/receptacles for separately holding respective drug groups during conveyance. Thus, Brink’s number of transport receptacles corresponds to a section structure capable of separately receiving drug groups/doses in their charged order and conveying the drug groups from the assessment area to the discharge area.
To the extent van den Brink does not expressly disclose the section structure as part of the modified conveyor-based conveyance inspection processing portion, Archer teaches a conveyor-based inspection system in which tablets are divided into a plurality of streams and conveyed past inspection systems (col. 3). Archer teaches that the tablet conveyor system divides tablets into a plurality of tablet streams for inspection by color, size, and shape, and that each inspection system inspects two parallel streams of tablets as they pass on the belt (col. 3). Archer further teaches four pairs of parallel tablet streams and four inspection systems (col. 4). Thus, Archer teaches the use of plural conveyor sections/streams and plural inspection systems for dividing conveyed tablets into a predetermined number of sections/streams for parallel inspection.
Regarding the limitation that when a plurality of the drug groups are continuously charged, the inspection control portion executes the inspection process for a previously charged drug group and the inspection process for a subsequently charged drug group in parallel, at different start timings, Brink expressly teaches that the method is for sequentially composing individualized compound doses of medicines, but the steps for consecutive individualized compound doses may take place simultaneously, i.e., processed in parallel, but mutually staggered in step (par [0012]). Brink further teaches that a previously received individualized compound dose may be assessed and/or checked while a following individualized compound dose is being received, thereby increasing output (par [0013]). Therefore, Brink teaches parallel processing of a previously charged dose and a subsequently charged dose at different/staggered start timings.
It would have been obvious to one of ordinary skill in the art to configure the modified van den Brink/Archer apparatus to use plural sections/receptacles or plural conveyor sections for continuously charged drug groups and to execute the inspection processes for consecutive drug groups in parallel at staggered timings, because Brink expressly teaches that parallel, staggered processing of consecutive doses increases output, and Archer teaches using multiple parallel inspection streams/systems to increase production and inspection throughput. The modification would have predictably improved throughput by allowing a subsequent dose to begin receiving/conveyance/inspection operations while a previous dose is still undergoing another portion of the inspection/discharge process.
Regarding claim 5, Regarding the limitation that the conveyance path is formed from a transparent material, Brink teaches that the transport receptacle slides over a glass plate, and that the glass plate is hard so that the pills can slide well over its surface (par [0057]). Van den Brink further teaches that the transport receptacle is open at the bottom and that the open bottom in combination with the glass plate allows the pills in the receptacle to be inspected by the camera from the bottom and also allows backlight to pass (par [0057]). Thus, van den Brink teaches a transparent glass plate forming a path/support surface for the medicines during inspection.
Regarding the limitation that the inspection imaging portion has an upper camera that is installed on an upper side of the conveyance path and takes images of the individual drugs on the conveyance path from the upper side, Brink teaches an automated recognition apparatus including a top digital camera to take photos of the dose at the checking position (par [0034]). Brink further teaches that the top camera takes a color picture of the pills in the dose (par [0073]).
Regarding the limitation that the inspection imaging portion has a lower camera that is installed on a lower side of the conveyance path and takes images of individual drugs on the conveyance path from the lower side, with light transmitted through the conveyance path, van den Brink teaches that the automated recognition apparatus includes a bottom digital camera, and further teaches that the open bottom of the receptacle in combination with the glass plate allows the pills in the receptacle to be inspected by the camera from the bottom and also allows backlight to pass (par [0034] [0054]). Van den Brink also teaches that the top camera takes a contrast picture against light passing through the glass bottom into the receptacle (par [0073]). Therefore, van den Brink teaches imaging pills through a transparent conveyance/support path using transmitted light.
Van den Brink does not expressly teach that the lower camera is located at a position shifted from an installation position of the upper camera by a predetermined amount in the conveyance direction.
However, Archer teaches a conveyor-based tablet inspection system in which tablets are conveyed in streams along a belt to an inspection system, and the inspection system uses cameras and image-processing hardware to inspect the tablets (col. 6). Archer further teaches that objects pass under cameras on a belt and that the belt runs at a known speed (col. 17). Therefore, Archer teaches performing camera inspection of tablets as the tablets move along a conveyance direction.
It would have been obvious to one of ordinary skill in the art to arrange the upper and lower cameras of Brink at offset positions along the conveyance direction when applying van den Brink’s upper/lower transparent-path imaging arrangement to Archer’s moving conveyor inspection system. Such an arrangement would have been a predictable mechanical implementation to provide mounting space for both cameras and associated illumination under and above the conveyor, while allowing the same tablet or drug group to be imaged from both sides as it moves along the known conveyance direction. Because Archer teaches conveying tablets at a predetermined belt speed, the system would predictably associate the upper-side and lower-side images based on the known amount of camera offset and the known conveyance speed. The amount of offset would have been a matter of routine design selection depending on camera size, illumination arrangement, optical path, and available installation space.
Regarding claim 6, Regarding the limitation that the inspection imaging portion has reflection illumination that is installed on the same side as the camera when viewed from the conveyance path, and illuminates individual drugs on the conveyance path from an oblique side surface, Archer teaches an inspection system for inspecting tablets on a moving conveyor belt. Archer teaches that the inspection system uses line scan cameras to inspect the tablets for color, shape, size, and damage (col. 6). Archer further teaches that the tablets are illuminated by two light strips from optical fiber light guides symmetrically disposed on each side of the vertical, which provides maximum intensity of illumination on the tablets while minimizing illumination of the belt (col. 7). Thus, Archer teaches reflection illumination installed on the same side of the conveyance path as the camera, with the illumination directed obliquely toward the tablets on the conveyance path.
It would have been obvious to one of ordinary skill in the art to use Archer’s oblique same-side reflection illumination in the modified van den Brink/Archer apparatus because Archer teaches that such illumination provides maximum illumination intensity on the tablets while minimizing illumination of the belt. The modification would have predictably improved the image quality of the individual drugs on the conveyance path, thereby improving automated recognition of drug color, shape, size, markings, and damage.
Regarding claim 7, Regarding the limitation that the conveyance path is formed from a transparent material, Brink teaches that the transport receptacle slides over a glass plate, and that the transport receptacle may have an open top and bottom and slide over a hard bottom, such as a glass plate. Brink further teaches that the open bottom in combination with the glass plate allows the pills in the receptacle to be inspected by a camera from the bottom and allows backlight to pass. Thus, van den Brink teaches a transparent conveyance/support path.
Regarding the limitation that the inspection imaging portion has transmission illumination that is installed on a side opposite to the camera when viewed from the conveyance path, with respect to the camera, in addition to the reflection illumination, and illuminates individual drugs on the conveyance path from a back surface side, with light transmitted through the conveyance path, Brink teaches an automated recognition apparatus including a top digital camera and a bottom digital camera for taking photos of the dose at the checking position, as well as lights for enhancing lighting of the pills (par [0052]). Van den Brink further teaches bottom lights and a semitransparent mirror that allow either reflection or passing through of image-enhancing light emitted from the bottom lights, so as to allow an image to be taken against the light to obtain a clear image of the contours of the pills (par [0052]). Therefore, van den Brink teaches transmission/backlight illumination arranged on an opposite side of the transparent support path from a camera, with light transmitted through the glass plate/support path to image the pills from the back side.
Regarding the limitation that the camera performs first photographing for acquiring a forward light image of a surface of the individual drug by taking a picture with reflection illumination turned on and transmission illumination turned off, Archer teaches that the tablets are illuminated by two light strips from optical fiber light guides disposed on each side of the vertical, which provides maximum illumination intensity on the tablets while minimizing illumination of the belt (col. 7). Thus, Archer teaches acquiring an image of the tablet surface using same-side reflection illumination.
Regarding the limitation that the camera performs second photographing for acquiring a backlight image in which an outer shape of the individual drug has been imaged by taking a picture with the reflection illumination turned off and the transmission illumination turned on, Brink teaches using light emitted from bottom lights to allow an image to be taken against the light to obtain a clear image of the contours of the pills (par [0052]). Therefore, van den Brink teaches using transmitted/backlight illumination to obtain an outer-shape/contour image of the pills.
To the extent Brink and Archer do not expressly teach the exact sequence of turning the reflection illumination on while the transmission illumination is off for the first image, and turning the reflection illumination off while the transmission illumination is on for the second image, it would have been obvious to one of ordinary skill in the art to separately and sequentially control the reflection illumination and transmission illumination when acquiring the two different types of images. Archer teaches electronically controllable illumination for tablet inspection (col. 7), and Brink teaches that the optical system may use either reflected light or transmitted/backlight to obtain different image information (par [0034]). Turning off the unused illumination during each respective image capture would have been an obvious implementation choice to avoid mixing reflected-light information with transmitted-light/backlight information, thereby improving contrast and allowing the system to separately obtain a surface/color image and an outer-shape/contour image.
It would have been obvious to one of ordinary skill in the art to combine Archer’s same-side reflection illumination with Brink’s transmitted/backlight imaging because both references are directed to automated optical inspection of pharmaceutical tablets/pills, and the combination would predictably improve automated drug recognition by obtaining both surface information, such as color/markings, and outline/contour information, such as shape and size.
Regarding claim 8, Regarding the limitation that the inspection imaging portion has a semi-transmission sheet that is arranged between the transmission illumination and the conveyance path, Brink teaches that the automated recognition apparatus includes a semitransparent mirror to allow either reflection or passing through of image-enhancing light emitted from bottom lights, so as to allow an image to be taken against the light to obtain a clear image of the contours of the pills (par [0052]). Brink further teaches that the transport receptacle is open at the bottom and slides over a glass plate, and that the open bottom in combination with the glass plate allows the pills to be inspected from the bottom and allows backlight to pass (par [0057]). Thus, Brink’s semitransparent mirror corresponds to the claimed semi-transmission sheet, and van den Brink’s bottom lights correspond to the claimed transmission illumination.
Regarding the limitation that the semi-transmission sheet transmits illuminated light by the transmission illumination, Brink expressly teaches that the semitransparent mirror allows passing through of image-enhancing light emitted from bottom lights, thereby allowing an image to be taken against the light to obtain a clear contour image of the pills (par 0052]). Therefore, Brink teaches transmitting illumination from the backlight/transmission illumination side through the optical member toward the pills/conveyance path.
Regarding the limitation that the semi-transmission sheet does not reflect illuminated light by the reflection illumination, Archer teaches reflection illumination on the camera side of the conveyance path (col. 7), and Brink teaches using the semitransparent mirror with bottom lights/backlight to obtain a contour image (par [0052]). In the combined apparatus, the semitransparent mirror/sheet is arranged on the transmission-illumination side, while the reflection illumination is arranged on the camera side for surface imaging. Thus, during reflected-light imaging, the reflection illumination is not used as the light source for the semitransparent mirror/sheet. Further, to the extent the claim requires that the semi-transmission sheet have a non-reflective property with respect to the reflected illumination, it would have been obvious to one of ordinary skill in the art to select or configure the semitransparent optical member so that it does not undesirably reflect the reflection illumination, because avoiding unwanted reflection/glare from the background or conveyance path would improve image contrast and tablet/drug identification accuracy. Archer teaches that its optical-fiber light guide arrangement is selected to provide maximum illumination on the tablets while minimizing illumination of the belt (col. 7), which supports the desirability of reducing unwanted reflected light from non-tablet/background surfaces.
It would have been obvious to one of ordinary skill in the art to use Brink’s semitransparent mirror/sheet in the modified Brink/Archer apparatus because Brink teaches that the semitransparent mirror allows backlight/transmission illumination to pass so as to obtain a clear image of pill contours, while Archer teaches reflected-light illumination for surface imaging. Combining these known optical arrangements would have predictably allowed the inspection imaging portion to acquire both surface/color information and contour/outer-shape information, thereby improving drug recognition accuracy.
Regarding claim 9, Regarding the limitation that the inspection imaging portion alternately, periodically and continuously performs the first photographing and the second photographing, in the photographing by the camera, Brink teaches using different illumination modes to obtain different image information of the pills. Specifically, Brink teaches that the automated recognition apparatus includes a top digital camera and a bottom digital camera for taking photos of the dose at the checking position, lights for enhancing lighting of the pills, and a semitransparent mirror to allow either reflection or passing through of image-enhancing light emitted from bottom lights so as to allow an image to be taken against the light to obtain a clear image of the contours of the pills (par [0052]). Thus, Brink teaches using reflected-light imaging and transmitted/backlight imaging to obtain both ordinary pill image information and contour information.
Archer teaches continuous automated tablet inspection using a conveyor and line-scan cameras. Archer teaches that the tablet conveyor system transports tablet streams to an inspection system, and that the belt typically runs at a predetermined speed (col. 5). Archer further teaches that the inspection system uses line-scan cameras connected to framestore and image pre-processing hardware, which extracts edge and color information from scanline data (col. 6), and that an interrupt is generated at the end of each scanline (col. 6). Archer also teaches controlled illumination for resolving differences between tablet shades and computer/control-system operation of the inspection system (col. 6).
Therefore, Archer teaches continuously and periodically acquiring image data from tablets moving on a conveyor, while Brink teaches the two different illumination/image modes recited in claim 7. It would have been obvious to one of ordinary skill in the art to configure the modified Brink/Archer apparatus to alternately and periodically switch between the reflected-light photographing mode and the transmitted/backlight photographing mode while continuously photographing drugs moving along the conveyance path. Such timing control would have been a predictable implementation of known camera/illumination control in a moving conveyor inspection system, and would allow the same inspection imaging portion to repeatedly acquire both surface/color image information and outer-shape/contour image information from the moving drugs.
The motivation for the modification would have been to improve the reliability of automated drug identification by repeatedly obtaining complementary image data: a reflected-light image useful for surface characteristics such as color and markings, and a transmitted/backlight image useful for outer shape and contour. Periodic alternating of the illumination states would also avoid mixing reflected-light information with transmitted-light information in the same image, thereby improving image contrast and simplifying image processing.
Regarding claim 10, Regarding the limitation that the post-inspection storage portion has a storage portion camera that takes an image of a storage space of the post-inspection storage portion, Brink teaches that, after the individualized compound dose has been checked, the receptacle is slid along the glass plate to the discharge position, where the pills exit the receptacle and fall via the aperture into the chute (par [0060]). Brink further teaches that, after discharge of the received and checked individualized compound dose of medicines, the discharging area is inspected for any remaining medicines using a drop clearance camera (par [0078]). The post-check discharge area/receptacle/chute region corresponds to the claimed post-inspection storage portion or storage space because it is the area that temporarily receives/holds the checked drug group after inspection and from which the drug group is discharged out of that area for packaging or disposal.
Regarding the limitation that the post-inspection storage portion performs an operation of discharging the drug group to the outside of the apparatus, then takes an image of the storage space by the storage portion camera, and confirms that all the drugs constituting the drug group have been discharged, on the basis of the captured image, Brink teaches that, after checking, the pills exit the receptacle and fall via the aperture into the chute (par [0060]). Brink further teaches that, when the dose check is positive, the dose is discharged to a dose compartment of a multi-dose compartment blister package (par [0030]), and when the dose check is negative, the dose is discharged to a disposal bin (par [0030]). Brink expressly teaches that after discharge of the received and checked individualized compound dose of medicines, the discharging area is inspected for any remaining medicines using the drop clearance camera (par [0078]), and that a digital photo of the discharging area after discharge is stored in the record for the individualized compound dose (par [0078]). Inspecting the discharging area for any remaining medicines after discharge corresponds to confirming, based on the captured image, that all medicines of the dose have been discharged and that no medicines remain in the storage/discharge space.
To the extent Brink does not expressly state that the image-based remaining-medicine inspection is performed by the same control portion recited in claim 1, it would have been obvious to one of ordinary skill in the art to have the inspection/control computer of Brink perform the remaining-medicine confirmation based on the captured image from the drop clearance camera, because Brink already teaches automated recognition, image analysis, and computer checking of medicine composition against a record. Using the same automated control system to determine whether any pills remain in the post-discharge storage/discharge space would have been a predictable use of known image inspection to prevent carryover of medicines into a later dose and to improve dispensing reliability.
Regarding claim 11, regarding the limitation that the inspection control portion can display at least one of an initial screen of inspection selection, which displays an implementation state of the inspection process for the drug group and an inspection result of the inspection process, Archer teaches a computer-controlled tablet inspection/filling system having an operator terminal including a video display unit and an operator input in the form of a keyboard (col. 11). Archer teaches that the filling station control receives commands from the operator keyboard, displays information on the screen, coordinates distributed controllers, responds to detected error conditions, and processes and stores data (col. 11). Archer further teaches operating states such as standby, changeover, maintenance, teach, run, paused, cycle stop, clear, pause, and emergency stop, and teaches that all states allow full-page viewing of an event log (Table 1, col. 13). Archer also teaches displaying error messages on the operator terminal and maintaining a history log including production information, error messages, operating state changes, operator input, and tablet model data used in the inspection system (col. 13). Thus, Archer teaches displaying implementation/operating state information and inspection-related result information to the user.
Brink teaches that the inspection process checks the assessed composition of an individualized compound dose of medicines against a record for that dose and discharges the dose differently depending on whether the check is positive or negative (par [0030]). Thus, Brink teaches inspection result information for a drug group/dose. It would have been obvious to display Brink’s inspection result and inspection state information on Archer’s known operator terminal/display so that an operator or pharmacist can monitor the state and outcome of the drug inspection process.
Regarding the limitation that the inspection control portion can display an inspection process screen that displays detailed information concerning an inspection result of the inspection process, Archer teaches that the inspection system processes objects for color, size, and shape, validates the objects against stored reference/model data (col. 14), and sends the result of the check to the diverter control (col. 14). Archer further teaches that the system maintains a history log including tablets rejected, tablets recycled, error messages, operating state changes, operator input, and tablet model data used in the inspection system (col. 13). Thus, Archer teaches storing and displaying detailed inspection/process information related to the inspection result.
Regarding the limitation that the inspection control portion can display an inspection correction screen that can receive correction by a user, for a drug that does not match a drug which is indicated in the prescription data of the drug group among drugs which have been identified from the captured image in the inspection process, according to the inspection situation, Brink teaches that the device checks the assessed composition of the received individualized compound dose of medicines against a record for the composition of that individualized compound dose of medicines (par [0029]). Brink also recognizes the situation in which the check reveals that a dose has not been composed properly and explains that the composition of the dose may need to be amended and rechecked manually (par [0037]). Archer teaches an operator terminal including both a display and keyboard input, and teaches that operator input and inspection-related data are processed/stored by the control system (col. 11). Therefore, it would have been obvious to provide a user correction screen on the operator terminal to allow the operator/pharmacist to correct or amend the inspection result or dose information when the identified drug does not match the prescription record, so that the amended result or dose can be rechecked as taught by Brink.
The motivation to combine would have been to improve usability, traceability, and reliability of the automated drug inspection apparatus by allowing the operator to view inspection states/results and to resolve inspection mismatches through the same operator display/input interface used for controlling and monitoring the automated inspection system. The modification would have been a predictable use of Archer’s known operator terminal/display/input interface in Brink’s automated prescription-dose inspection system.
Regarding claim 12, Regarding the limitation that the inspection control portion configures the inspection correction screen so that the user can select and settle the type of the drug from the drugs registered in the master data, when the type of the drug which has been identified from the captured image in the inspection process cannot be specified, and displays the inspection correction screen, Brink teaches that the automated recognition apparatus analyzes images of the dose to extract pill-identifying characteristics, such as size, shape, color, texture, and markings, and compares the photo to images stored in a database or library (par [0074]). Thus, van den Brink teaches using stored database/library information corresponding to registered master data for determining the type of the drug from captured images.
Brink further teaches that the computer checks the assessed composition of the individualized compound dose against a record for the composition of that individualized compound dose, and recognizes the situation in which the check reveals that a dose has not been composed properly (par [0029]). Brink explains that, in such a situation, the composition of the dose may need to be amended and rechecked manually (par [0037]). Therefore, Brink teaches a drug identification/verification system in which an unsuccessful or mismatching automated identification result may require manual amendment and rechecking.
Archer teaches an operator terminal including a video display unit and an operator input in the form of a keyboard (col. 11). Archer further teaches that the control system receives commands from the operator keyboard, displays information on the screen, and processes and stores data (col. 11). Archer also teaches entry of batch/tablet data by the operator, a teach state in which the system learns tablet model data, and checking the teach data against a master record for standards of the particular tablet being packaged (col. 12).
Accordingly, it would have been obvious to one of ordinary skill in the art to configure the inspection correction screen of the modified van den Brink/Archer apparatus to allow the user to select and settle the correct drug type from registered drug master data when the automatic image-identification process cannot specify the type of the drug. Such a screen would merely apply Archer’s known operator display/input interface and master-record/model-data selection functionality to Brink’s known drug database/library and manual amendment/recheck process.
The motivation would have been to permit a pharmacist or operator to resolve uncertain or failed automated recognition results using the same registered drug data used by the automated inspection system, thereby improving reliability and traceability of the inspection result and allowing the dose to be corrected or rechecked without discarding the entire dose.
Regarding claim 14, Brink teaches a drug inspection method by a drug inspection apparatus that inspects dispensed drugs. Specifically, van den Brink teaches a method of receiving and checking individualized compound doses of medicines, including receiving a plurality of dispensed medicines that form an individualized compound dose of medicines (par [0027]), assessing the composition of the individualized compound dose of medicines through automated analysis/recognition of the received medicines (par [0028]), checking the assessed composition against a record for the composition of that individualized compound dose of medicines (pr [0029]), and discharging the dose differently depending on whether the outcome of the check is positive or negative (par [0030]).
Brink teaches a pre-inspection storage portion that temporarily stores a drug group which is a plurality of drugs collectively charged, because Brink teaches a receiving area/dose buffer for receiving the plurality of dispensed medicines forming an individualized compound dose of medicines (par [0027]). The individualized compound dose corresponds to the claimed drug group.
Brink teaches a transfer processing portion that transfers the drug group to a conveyance path, because Brink teaches that a received individualized compound dose is moved from a receiving area/dose buffer to a separate assessment area for checking, and teaches transport receptacles arranged to receive a dose from the dose buffer and confine the dose during transport (par [0033]).
Brink teaches a conveyance inspection processing portion having an inspection imaging portion that takes images of the individual drugs, because Brink teaches an automated recognition apparatus including a top camera and bottom camera for taking pictures of the pills in the dose (par [0034]). Brink further teaches that the composition of the individualized compound dose is assessed via automated recognition, including analyzing the captured image to extract pill-identifying characteristics such as size, shape, color, texture, and markings (par [0074]).
Brink teaches a discharge processing portion that discharges the imaged drug group to a post-inspection storage portion, and the post-inspection storage portion temporarily stores the drug group and then discharges the drug group to the outside of the apparatus, because Brink teaches that after checking, the pills exit the receptacle and fall via an aperture into a chute (par [0035]). Brink further teaches that if the dose check is positive, the individualized compound dose is discharged to a dose compartment of a multi-dose compartment package (par [0030]), and if the dose check is negative, the dose is discharged to a disposal bin (par [0063]). Brink also teaches that a dose may be discharged through an intermediate tray or buffer before being discharged to a dose compartment (par [0036]).
Brink teaches an inspection control portion that performs image identification using registered master data, identifies the type and number/composition of the imaged individual drugs, checks whether the identified content matches prescription data, and notifies an inspection result, because Brink teaches that the automated recognition process analyzes images and compares the photo to images stored in a database or library (par [0029]). Brink further teaches that a computer checks the assessed composition of the individualized compound dose against a record for the composition of that dose, which corresponds to the prescription data (par [0070]), and discharges the dose based on the positive or negative inspection result (par [0030]).
Brink does not expressly teach that the drugs are spread in an elongated and substantially one row, transferred while maintaining the spread state, and conveyed on a conveyance path at a predetermined speed.
However, Archer teaches a tablet inspection system including a tablet hopper, vibratory feeder, conveyor system, inspection system, diverter system, and computer control (abstract). Archer teaches that the vibratory feeder produces well-defined and singulated streams of tablets (col. 5), and that the tablet streams are fed to a conveyor system (col. 5). Archer further teaches that the conveyor system transports each stream of tablets to an inspection system, and that the belt typically runs at a speed of 200 mm/sec (col. 5). Archer also teaches that the inspection system uses line-scan cameras and image-processing hardware to inspect tablets for color, shape, size, and damage (col. 6).
It would have been obvious to one of ordinary skill in the art to modify van den Brink’s drug inspection method and apparatus to use Archer’s vibratory feeder and conveyor-based inspection arrangement so that the plurality of pills forming a dose are spread into a substantially one-row arrangement and conveyed at a predetermined speed to the imaging/inspection portion. The motivation would have been to reduce pill overlap and improve the reliability and speed of automated optical recognition. Brink itself recognizes that pills may not be clear of each other and may need additional separation before identification, while Archer teaches a known pharmaceutical-tablet handling technique for producing well-defined singulated streams and conveying them through an inspection system.
It would further have been obvious to software-control the operations of the pre-inspection storage portion, transfer processing portion, conveyance inspection processing portion, discharge processing portion, post-inspection storage portion, and inspection process because Brink teaches computer-based checking and automated recognition, and Archer teaches a distributed computer control system controlling the vibratory feeder, tablet conveyor, inspection systems, diverter mechanisms, and related operational states. Combining these known controls would have predictably automated the handling, imaging, comparison, and discharge operations of the modified drug inspection method.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brink in view of Archer as applied to claims 1, 3, 5-12 and 14, and further in view of Shail (US 2012/0096816).
Regarding claim 2, Brink and Archer teach the drug inspection apparatus of claim 1 as discussed above.
Brink and Archer do not expressly teach that the pre-inspection storage portion forms a storage space for the drug group so that an inclined surface is V-shaped and a bottom surface is elongated, and causes the individual drugs of the drug group to be spread in an elongated and substantially one row on the bottom surface by vibrating a constituent member of the inclined surface.
However, Shail teaches a tablet-container filling apparatus for feeding and separating tablets, and teaches that a typical filling machine separates tablets into a single-file arrangement, termed “singulating,” and then counts the tablets as they pass through a sensing device on their way into the container (par [0004]). Shail further teaches that conventional color-sensing cameras are often mounted above the singulating device, “for example, being a vibrating tray having multiple V shaped channels, with each channel transporting one row of tablets.” (par [0006]). Therefore, Shail teaches a vibrating tray having V-shaped channels, wherein each V-shaped channel provides inclined surfaces and an elongated bottom/path for transporting one row of tablets.
It would have been obvious to one of ordinary skill in the art to modify the vibratory feeder/singulating arrangement of Archer, as applied to van den Brink, to use Shail’s known vibrating tray having multiple V-shaped channels, each transporting one row of tablets, because Shail teaches that this was a known singulating structure for separating tablets into a single-file flow for inspection/counting. Such modification would have predictably improved the combined system by guiding tablets by gravity and vibration into a stable one-row arrangement, thereby reducing overlap and improving automated optical inspection accuracy.
Regarding the limitation that the transfer processing portion transfers the drug group to the conveyance path along a direction in which the drug group is conveyed on the conveyance path, Archer teaches that the vibratory feeder produces well-defined and singulated streams of tablets, and that the four pairs of tablet streams are fed to a conveyor system (col. 5, line 41-43). Archer further teaches that the conveyor system transports each of the tablet streams to an inspection system for sorting prior to bottle filling (col. 5, line 56-59). Thus, Archer teaches transferring the singulated tablet streams from the vibratory feeder to the conveyor path in the same downstream direction in which the tablets are conveyed toward the inspection system.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Brink in view of Archer as applied to claims 1, 3, 5-12 and 14, and further in view of Kondo et al. (US 2014/0318078) (Kondo).
Regarding claim 4, Brink and Archer do not expressly teach that the conveyance inspection processing portion has a rotary disc that rotates as the conveyance path, and drug mounting areas which are obtained by division of the rotary disc into N parts with a predetermined width of an outer circumference in a rotation direction, as the section structure.
However, Kondo teaches a medicine inspection apparatus including a turntable. Specifically, Kondo teaches an inspection apparatus 100 including “a turntable 102 that is supported by an electric mechanism 101 so as to be able to rotate” (par [0073]) and an inspection container 103 “into which a medicine TB for a package (a dose) is introduced.” Kondo further teaches that inspection containers 103 are arranged on the turntable 102 corresponding to a solid medicine introduction position S1, an imaging position S2, a filling position S3, and a disposal position S4, and that these positions are arranged at substantially equal intervals (par [0073]). Kondo also teaches that, in one configuration, six inspection containers 103 are mounted on the turntable 102 at substantially equal angular intervals (par [0078]).
Therefore, Kondo teaches a rotary disc/turntable that rotates as a conveyance path, and teaches plural dose-holding areas/inspection containers arranged at substantially equal angular intervals on the turntable. The inspection containers and corresponding equal angular regions of the turntable correspond to the claimed drug mounting areas obtained by division of the rotary disc into N parts with a predetermined width in the rotation direction.
Regarding the limitation that when the drug mounting area which mounts the drug group thereon passes through a predetermined range, by the rotation of the rotary disc, the inspection imaging portion takes a picture of the drug mounting area, Kondo teaches that the inspection apparatus receives the medicine TB in the inspection container 103 at the solid medicine introduction position S1 and then rotates the turntable 102 by the electric mechanism 101 to move the inspection container 103 to the imaging/photographing position S2. Kondo further teaches that the medicine TB in the inspection container 103 is imaged by a photographing device 104 at the photographing position S2, and that the result of the photographing is compared with prescription data (par [0073]). Thus, Kondo teaches taking a picture of the dose-holding area/inspection container when that area reaches or passes through the predetermined photographing range/position due to rotation of the turntable.
It would have been obvious to one of ordinary skill in the art to modify the conveyance/inspection structure of Brink and Archer to use Kondo’s known turntable having plural dose-holding inspection containers arranged at substantially equal angular intervals, because Kondo teaches that such a turntable arrangement allows solid medicine introduction, photographing, filling, and disposal positions to be arranged around a compact rotating mechanism. The modification would have predictably improved the combined drug inspection apparatus by providing a compact sectioned conveyance path that can sequentially move each dose through introduction, imaging, and discharge/disposal stations, thereby increasing processing efficiency and reducing apparatus size.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Brink in view of Shail, and further in view of Jacobs et al. (US 2012/0330684) (Jacobs).
Regarding claim 13, Brink teaches a drug inspection apparatus that inspects dispensed drugs (abstract). Specifically, Brink teaches a device for receiving and checking individualized compound doses of medicines, including a receiving area for receiving a plurality of dispensed medicines that form an individualized compound dose of medicines (par [0027]), an assessment area with automated recognition apparatus for assessing the composition of the individualized compound dose of medicines through automated recognition of the received medicines (par [0028]), a computer that checks the assessed composition against a record for the composition of that individualized compound dose of medicines (par [0029]), and a discharge that discharges the dose differently depending on whether the outcome of the check is positive or negative (par [0030]).
Brink teaches a pre-inspection storage portion that temporarily stores a drug group which is a plurality of drugs collectively charged, because Brink teaches a dose buffer that receives and collects pills dispensed in accordance with a patient prescription record to form an individualized compound dose of medicine (par [0031]).
Brink teaches a transfer processing portion that transfers the drug group to a predetermined mounting plane, because Brink teaches that, when the dose is collected in the buffer, a drop bottom opens and forms a chute that conveys the dose to a transport receptacle at the dose checking position (par [0033]). Brink further teaches that the receptacle receives the dose via its open top and holds the pills on a glass plate (par [0057]). The glass plate corresponds to the claimed predetermined mounting plane.
Brink teaches an inspection imaging portion that takes images of individual drugs of the drug group transferred to the predetermined mounting plane, because Brink teaches that the top camera and bottom camera each take a color picture of the pills in the dose, and that the top camera also takes a contrast picture against light passing through the glass bottom into the receptacle (par [0052]). Brink further teaches that the composition of the individualized compound dose is assessed via automated recognition by analyzing the picture to extract pill-identifying characteristics, including size, shape, color, texture, and markings (par [0074]).
Brink teaches a discharge processing portion arranged below the predetermined mounting plane and discharging the drug group after imaging, because Brink teaches that after checking, the receptacle is slid along the glass plate to the discharge position, where the pills exit the receptacle and fall via an aperture into a chute (par [0075]). Brink further teaches that the discharge area includes a chute connected to an aperture in the hard plate forming the entry of the chute (par [0075]).
Brink teaches a post-inspection storage portion that temporarily stores the drug group discharged by the discharge processing portion and then discharges the drug group to the outside of the apparatus, because Brink teaches discharging a correct dose to a dose compartment of a multi-dose compartment package, and also teaches that the device may include an intermediate tray or buffer tray having multiple compartments to receive medicines from the discharge and then discharge medicines to a multi-dose compartment package (par [0036]).
Brink teaches an inspection control portion that performs an inspection process using the captured image, because Brink teaches a computer that checks the assessed composition of the individualized compound dose against a record for that dose (par [0029]). Brink further teaches that the automated recognition analyzes captured images to extract pill-identifying characteristics and compares the photo to images stored in a database or library (par [0074]). Thus, Brink teaches using registered master data to identify the type and number/composition of the imaged drugs, comparing the identified content with prescription data, and outputting/notifying the inspection result by positive or negative discharge.
Brink does not expressly teach that the pre-inspection storage portion forms a storage space so that an inclined surface is V-shaped and a bottom surface is elongated, and spreads the drugs in an elongated short row and substantially one row by vibrating a constituent member of the inclined surface.
However, Shail teaches that a typical tablet filling machine includes apparatus for separating tablets into a single-file arrangement, termed “singulating.” (par [0004]). Shail further teaches that conventional color-sensing cameras are often mounted above a singulating device, for example, a vibrating tray having multiple V-shaped channels, with each channel transporting one row of tablets (par [0006]). Therefore, Shail teaches a vibrating V-shaped channel/tray structure that spreads tablets into an elongated substantially one-row arrangement.
It would have been obvious to one of ordinary skill in the art to modify van den Brink’s dose-buffer/receiving arrangement to include Shail’s known vibrating V-shaped channel/tray structure to spread the plurality of pills into an elongated substantially one-row arrangement before imaging. The motivation would have been to reduce overlap and improve optical inspection accuracy. Van den Brink itself recognizes that pills may need to be brought out of stacked or overlapping arrangement, and Shail provides a known pharmaceutical tablet-handling structure for singulating tablets into one row for optical inspection/counting.
Brink and Shail do not expressly teach that the images are taken by a camera movable above the predetermined mounting plane.
However, Jacobs teaches a medication verification apparatus having an imaging zone with one or more imaging devices, such as cameras, for taking images of medication (abstract). Jacobs further teaches that the imaging device may include a movable camera or scanning array with a fixed and/or movable lighting system that takes photographs or video images as the imaging device moves relative to the medication (par [0061]). Jacobs also teaches that a medication may be static during imaging, and that a holding area or trap door may hold the medication in place while the imaging device takes the picture and then release the medication to continue travel (par [0061]). Thus, Jacobs teaches a movable medication-imaging camera arrangement for imaging medication on or in a predetermined imaging area.
It would have been obvious to one of ordinary skill in the art to configure the camera of van den Brink, as modified by Shail, to be movable above the predetermined mounting plane as taught by Jacobs. The motivation would have been to allow the camera to image different regions of the spread drug group on the mounting plane and to improve identification of individual tablets within the dose, especially where the drug group is elongated or includes many tablets. Such a modification would have been a predictable use of a known movable medication-imaging camera in an automated medication verification apparatus.
Regarding the limitation that the predetermined mounting plane has a structure of being inclined downward and opening the front, thereby dropping the drug group after imaging to the discharge processing portion, Jacobs teaches that the guide tube or imaging surface can be angled so that the medication slides along a surface while the image is taken, and also teaches use of a holding area or trap door that holds medication in place while the image is taken and then releases the medication to continue travel (par [0060]). Brink further teaches that after checking, the pills fall via an aperture into a chute at the discharge area (par [0060]). Therefore, the combined teachings suggest an inclined imaging/mounting plane with an open/releasable downstream end that drops the imaged medication into a discharge path.
It would have been obvious to one of ordinary skill in the art to provide the predetermined mounting plane in the modified apparatus with a downward incline and open/releasable downstream end so that, after imaging, gravity assists discharge of the drug group to the discharge processing portion. The motivation would have been to simplify the discharge mechanism, reduce the need for additional pushing or conveyance mechanisms, and reliably transfer the imaged drug group from the imaging plane to the post-inspection storage/discharge path.
Conclusion
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797
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