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 .
Applicant's arguments filed 22 January 2026 have been fully considered but they are not persuasive.
Applicant argues Mahar does not teach or suggest that "at least one processor triggers the image capture device to capture the image of the at least one component and displays the image of the at least one component on the user interface for review by the operator during preparation of the pharmaceutical compound by the operator," as recited by amended independent claim 7.
Examiner respectfully disagrees and respectfully submits “during preparation” may be broad an considered any time pre-sale. Furthermore, Examiner respectfully submits while an embodiment of the prior art discloses storing image data for future review does not teach away from and enables immediate review.
Applicant argues one of skill in the art would have no motivation to modify Alouani in view of Mahar to reach the elements of amended independent claim 7, cited labor cost.
Examiner respectfully disagrees and respectfully submits a reference acknowledging shortcomings does not teach away from utilizing a component. For example, knowing an internal combustion engine produces excess heat does not teach away from using one in a system.
Applicant argues claim 14 recites "wherein a removal of the at least one component from the scale triggers the at least one processor to automatically provide on the user interface a next step of the instructions for preparing the pharmaceutical compound, accept the image, and associate the image with a data record." Applicant argues Moore is silent to a removal of envelopes or documents from the scale of the system of Moore being an automatic trigger event for a user interface providing a next step of the instructions. That is, paragraph [0074] of Moore provides no teaching or suggestion that the "light(s), sound(s), displayed instructions" are automatically triggered by removal of envelopes or documents from the scale of the system of Moore. In contrast, as disclosed in paragraph [0045] of the present application, "the captured image will be shown at the user interface 3 and by removing the item from the scale 9, the technician accepts the image and the system automatically moves to the next compounding step (block 330)." (Emphasis added). The foregoing features of the system for preparing a pharmaceutical compound of amended independent claim 14 satisfy the need "for a system that triggers an image capturing step when certain criteria of the drug preparation have been met and moves to the next step of the drug preparation without any additional user input" (emphasis in original). Therefore, Moore is silent to a removal of envelopes or documents from the scale of the system of Moore being an automatic trigger event for a user interface providing a next step of the instructions as well as the technical effect of eliminating the need for additional user input or active user steps, such as using a touch screen or foot pedal, to trigger a user interface to provide a next step of the instructions.
Examiner respectfully disagrees and respectfully submits the additional requirement of “without any additional user input” is not found in the claims. Furthermore, Moore discloses a response to a trigger. The response being showing instructions to a user. Teller discloses removal of an object may cause a process to trigger a response. Teller’s trigger for a response and Moore’s response to a trigger would be an obvious combination to one having ordinary skill in the art for the reasons specified.
Claim Rejections - 35 USC § 103
Claim(s) 7-8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alouani et al. (US 7028723 B1) in view of Maher et al. (US 9922171 B2).
Regarding Claim 7, Alouani discloses system for preparing a pharmaceutical compound [Alouani: Title] comprising; a scale operatively connected to the at least one processor [Alouani: Col. 2, ll. 12-14: The automatic prescription verification system is preferably equipped with a range sensor, a digital camera, and a scale]; and an image capture device operatively connected to the at least one processor and the scale and positioned to capture an image of at least one of a component used in preparing the compound and the compound [Alouani: Col. 7, ll. 31-35: The turn-table 320 then rotates again to bring the nest to a predetermined position on a scale 316, where a weight measurement is obtained. The turn-table 320 then rotates again to bring the nest to a predetermined position relative to a camera 314, where image data is obtained], wherein the scale transmits a signal to the at least one processor indicating that a weight detected thereby has changed when the at least one component is placed thereon [Alouani: Col. 6, ll. 46-60: The automatic prescription verification system 100 obtains actual image information and actual weight information about the filled prescription of pills in the pill bottle (step 208), and determines a prescription accuracy level (step 210) based on the actual image information and actual weight information in view of the expected image information and expected weight information associated with the prescription information. Generally, if the accuracy level is acceptable (determined in step 212), for example if the actual image information is within pre-defined image tolerance limits of expected image information and the actual weight information is within pre-defined weight tolerance limits of expected weight information, the filled prescription is accepted (step 214) and can be shipped to the consumer] and, based on the signal, the at least one processor triggers the image capture device to capture the image of the at least one component [Alouani: Col. 7, ll. 31-35; “wherein based on the signal” appears broad and the completion of the weighing step sending any signal which allows the process to proceed to the imaging step is “based on the signal”. If “triggers” is read as immediate, such disclosure is well-known and may be found in [Teller: ¶ [0145]: In one embodiment, the system of the present invention saves images during the duration of a specific event, for instance, the tilt of a dispensing container or the motion of a handle on a dispensing apparatus. FIG. 10 is a flowchart which illustrates the process for automatically identifying a trigger condition which saves the images. A similar method may also be used for data obtained from an RFID or barcode. In some embodiments the system may also saves images immediately before and after the triggering event, enhancing the context of the image or video of the dispensing event and providing information for auditing purposes]. Furthermore, the camera and scale are only required to be “operatively connected” with no restriction on their placement relative to one another].
Alouani may not explicitly disclose a computing device comprising a user interface providing an operator with instructions for preparing the compound and at least one processor operatively connected to the user interface; and displays the image of the at least one component on the user interface for review by the operator during preparation of the pharmaceutical compound by the operator.
However, Mahar discloses a system for preparing a pharmaceutical compound comprising: a computing device comprising a user interface providing an operator with instructions for preparing the compound and at least one processor operatively connected to the user interface [Mahar: Claim 1: A computerized method for processing vials on an automated dispensing line comprising: (a) assigning at a server to an automated tablet counter (ATC) identifier: (1) an ATC barcode; and (2) drug identifying data for a drug dispensed from said ATC said drug identifying data comprises a drug code and a drug dosage; (b) assigning at said server to a drug canister identifier a drug canister barcode; (c) assigning at said server to a canister security tag a security tag barcode; (d) receiving at said server a replenishment request comprising said ATC identifier; (e) transmitting a notification to a pharmacist requesting the pharmacist to verify the contents of the drug canister associated with the drug canister identifier: (1) displaying the notification to the pharmacist requesting the pharmacist to verify the contents of the drug canister on a pharmacist verification software module; and (2) displaying an image of a drug associated with the drug canister; (f) receiving at said server a pharmacist verification approval for said replenishment request confirming contents of said drug canister matches said drug identifying data; (g) receiving at said server barcode scan data for a scanned ATC, a scanned drug canister, and a scanned security tag; (h) confirming at said server said barcode scan data matches said ATC barcode, said drug canister barcode, and said security tag barcode; (i) receiving at said server filled prescription order data for a plurality of vials filled at said ATC; (j) transmitting a request to verify said order data and vial contents to a pharmacist, said request comprising filled prescription order data and an image of the contents of at least one of said plurality of vials; and (k) receiving at said server pharmacist order verification status for a specified number of said plurality of vials; and Col. 4, l. 61 through Col. 5, l. 7: Pharmacist verification is performed by capturing and displaying at a workstation the verification data that the pharmacist needs to review and verify a prescription order. The verification data includes prescribed drug data from the order (e.g., drug name, strength, dosage form, and quantity prescribed) and a digital image of a drug dispensed into a vial for shipment to the patient. The digital images are acquired from digital camera systems that are integrated into the automated dispensing line. During the fulfillment process, a digital image of every filled vial is captured and stored with the order data. The pharmacist reviews the prescription order data and image of the vial contents shown at the workstation to confirm the proper drug has been added to the vial to be dispensed to the patient], and displays the image of the at least one component on the user interface for review by the operator during preparation of the pharmaceutical compound by the operator [Mahar: Col. 4, l. 61 through Col. 5, l. 7: Pharmacist verification is performed by capturing and displaying at a workstation the verification data that the pharmacist needs to review and verify a prescription order].
It would have been obvious to one having ordinary skill in the art before the effective filing date to combine the image and weight verification of Alouani to the pharmaceutical compound verification of Mahar in order to provide higher accuracy quality control.
Regarding Claim 10, Alouani in view of Mahar disclose(s) all the limitations of Claim 8, and is/are analyzed as previously discussed with respect to that claim.
Furthermore, Alouani in view of Mahar discloses wherein the data record and images are transmitted to a pharmacist workstation for verification [Mahar: Claim 1].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alouani in view of Mahar as applied to claim 7 above, and further in view of Landa (US 2013/0271796 A1).
Regarding Claim 11, Alouani in view of Mahar disclose(s) all the limitations of Claim 7, and is/are analyzed as previously discussed with respect to that claim.
Alouani in view of Mahar may not explicitly disclose wherein, if the image is deemed to be unacceptable by the operator, the user interface is configured to provide the operator with the capability to recapture the image.
However, Landa discloses wherein, if the image is deemed to be unacceptable by the operator, the user interface is configured to provide the operator with the capability to recapture the image [Landa: Abstract: Unacceptable images are flagged for recapture].
It would have been obvious to one having ordinary skill in the art before the effective filing date to combine the compound verification system of Alouani in view of Mahar with the recapture of unusable images of Landa in order to ensure verification via imaging is achievable via usable images, improving accuracy and robustness.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alouani in view of Mahar as applied to claim 7 above, and further in view of Teller (US 2006/0238346 A1).
Regarding Claim 9, Alouani in view of Mahar disclose(s) all the limitations of Claim 7, and is/are analyzed as previously discussed with respect to that claim.
Furthermore, Alouani in view of Mahar discloses to provide instruction on the user interface to allow the operator to move to a next step of the instructions for preparing the pharmaceutical compound [Maher: Claim 1].
Alouani in view of Mahar may not explicitly disclose wherein a removal of the at least one component from the scale causes the at least one processor to accept the image, associate the image with a data record.
However, Teller discloses wherein a removal of the at least one component from the scale causes the at least one processor to accept the image, associate the image with a data record [Teller: ¶ [0145]; and ¶ [0178]: In some embodiments, the system of the present invention may exclude changes in weight that are not gradual from the change weight. In FIG. 14A there is shown at T.sub.0 a sudden increase in weight followed by a gradual increase from T.sub.0 to T.sub.1. The system of the present invention may flag this duration (T.sub.1-T.sub.0) to be reconciled with a tilt event. Also, in FIG. 14A there is a constant duration between T.sub.1 and T.sub.2 and may indicate no activity on the scale. During T.sub.1-T.sub.2 the weight stabilizes and an end weight may be determined. At T.sub.2 there is a rapid increase in weight and may indicate the addition of ice, fruit or other garnish. Between T.sub.2 and T.sub.f there is a constant period indicating no activity on the scale. At T.sub.f there is a rapid decrease in weight and may indicate the removal of the container from the scale. Once the weight returns to zero, the system records the T.sub.f and determines the scale time by subtracting T.sub.0 from T.sub.f].
It would have been obvious to one having ordinary skill in the art before the effective filing date to combine the image and weight verification of Alouani in view of Mahar with the combined image and scale processing of Teller in order to provide higher accuracy quality control.
Regarding Claim 12, Alouani in view of Mahar disclose(s) all the limitations of Claim 7, and is/are analyzed as previously discussed with respect to that claim.
Alouani in view of Mahar may not explicitly disclose wherein the image is saved to a database when the weight of the at least one component or the pharmaceutical compound on the scale has been verified by the at least one processor.
However, Teller discloses wherein the image is saved to a database when the weight of the at least one component or the pharmaceutical compound on the scale has been verified by the at least one processor [Teller: ¶ [0008]: According to a first broad aspect of the present invention, there is provided a method for monitoring the dispensing of a beverage into a container comprising the following steps: measuring a scale time for the container on a scale; measuring a end weight for the container on the scale; and determining that a dispense event has occurred for the beverage based on whether a tilt condition of a dispensing apparatus occurred substantially within the scale time and based on whether the end weight of the beverage dispensed into the container approximates a serving based on point-of-sale information].
Regarding Claim 13, Alouani in view of Mahar and Teller disclose(s) all the limitations of Claim 12, and is/are analyzed as previously discussed with respect to that claim.
Furthermore, Alouani in view of Mahar and Teller discloses further comprising a scanner operatively couple to the user interface, wherein the scanner is configured to scan a barcode provided on the at least one component and provide the at least one processor with information regarding the at least one component [Teller: ¶ [0145]: In one embodiment, the system of the present invention saves images during the duration of a specific event, for instance, the tilt of a dispensing container or the motion of a handle on a dispensing apparatus. FIG. 10 is a flowchart which illustrates the process for automatically identifying a trigger condition which saves the images. A similar method may also be used for data obtained from an RFID or barcode; Mahar: Col. 4, ll. 29-36; and Alouani: Col. 4, ll. 54-60].
Claim(s) 14-15, and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teller (US 2006/0238346 A1) in view of Mahar et al. (US 9922171 B2) and Moore et al. (US 2012/0127540 A1).
Regarding Claim 14, Teller discloses a system for preparing a pharmaceutical compound [Teller: Title; compound combination may include pharmaceuticals such as Mahar: Claim 1] comprising: a computing device comprising a user interface and at least one processor operatively connected to the user interface [Teller: ¶ [0086]], the user interface configured to display: instructions for preparing the pharmaceutical compound [Teller: ¶ [0086]]; and a listing of equipment and at least one component used in preparing the pharmaceutical compound [Teller: ¶ [0086]: ingredients]; a scale operatively connected to the at least one processor [Teller: ¶ [0085]]; and an image capture device operatively connected to the at least one processor and the scale and positioned to capture an image of the at least one component used in preparing the pharmaceutical compound and the pharmaceutical compound [Teller: ¶ [0086]; and FIG. 6C], wherein a removal of the at least one component from the scale triggers the at least one processor to automatically accept the image, and associate the image with a data record [Teller: ¶ [0145]; and ¶ [0178]].
Teller may not explicitly disclose provide on the user interface a next step of the instructions for preparing the pharmaceutical compound.
However, Moore discloses provide on the user interface a next step of the instructions for preparing the [process] [Moore: ¶ [0074]: In one embodiment, the user may be provided with cues, e.g., light(s), sound(s), displayed instructions, combinations thereof, or the like) for indicating when the next process step should be performed, e.g., prior to S104 and/or at S108].
It would have been obvious to one having ordinary skill in the art before the effective filing date to combine the image and weight verification of Alouani in view of Mahar with the combined image and scale processing of Teller in order to provide higher accuracy quality control as well as the instruction of Moore in order to provide training and guidance, improving accuracy.
Regarding Claim 15, Teller in view of Mahar and Moore disclose(s) all the limitations of Claim 14, and is/are analyzed as previously discussed with respect to that claim.
Furthermore, Teller in view of Mahar and Moore disclose wherein the image of the at least one component is displayed on the user interface for review by an operator [Mahar: Claim 1].
Regarding Claim 17, Teller in view of Mahar and Moore disclose(s) all the limitations of Claim 14, and is/are analyzed as previously discussed with respect to that claim, furthermore, note the Examiner’s rejection for Claim 10. The Examiner notes the system of Claim 17 can be implemented by the system of Claim 10.
Regarding Claim 18, Teller in view of Mahar and Moore disclose(s) all the limitations of Claim 14, and is/are analyzed as previously discussed with respect to that claim.
Furthermore, Teller in view of Mahar and Moore discloses further comprising a scanner operatively coupled to the user interface [Teller: ¶ [0008]; and Alouani: Col. 4].
Regarding Claim 19, Teller in view of Mahar and Moore disclose(s) all the limitations of Claim 18, and is/are analyzed as previously discussed with respect to that claim.
Furthermore, Teller in view of Mahar and Moore discloses wherein the scanner is configured to scan a barcode provided on the at least one component and provide the at least one processor with information regarding the at least one component [Teller: ¶ [0008]].
Regarding Claim 20, Teller in view of Mahar and Moore disclose(s) all the limitations of Claim 19, and is/are analyzed as previously discussed with respect to that claim.
Furthermore, Teller in view of Mahar and Moore discloses wherein the scanner is arranged in a housing positioned above the scale [Teller: FIG. 6C].
Regarding Claim 21, Teller in view of Mahar and Moore disclose(s) all the limitations of Claim 20, and is/are analyzed as previously discussed with respect to that claim.
Furthermore, Teller in view of Mahar and Moore discloses wherein the housing has a streamlined shape to minimize flow when the system is arranged within a flow hood [Teller: FIG. 6C].
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN R MESSMORE whose telephone number is (571)272-2773. The examiner can normally be reached Monday-Friday 9-5 EST/EDT.
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/JONATHAN R MESSMORE/Primary Examiner, Art Unit 2482