DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to a request for continued examination (“RCE”) filed 8 June 2026, on an application filed 30 March 2023, which is a national stage entry of a PCT application that claims priority to a provisional application filed 14 October 2020.
Claims 5 and 10 have been amended.
Claims 5-8, 10-13 and 18-23 are currently pending and have been examined.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4 May 2026 has been entered.
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 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 of this title, 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 5-8 and 10-13 are rejected under 35 U.S.C. 103 as being obvious over Lang et al. (U.S. PG-Pub 2013/0142406 A1), hereinafter Lang, further in view of Takashima et al. (U.S. PG-Pub 2020/0098462 A1), hereinafter Takashima and Holmes (U.S. PG-Pub 2021/0161767 A1).
As per claims 5 and 10, Lang discloses a method for remote verification for a pharmaceutical counting and packaging device and a pharmaceutical counting and packaging device (Lang, see Figs. 1 and 4-7.) comprising:
a counting tray configured to receive medications for counting (Lang, stage at Fig. 1 #14 and Fig. 5 #122.);
a camera system for capturing images (Lang, Fig. 1 #22 and 5 #118.);
a transceiver (Lang, device interface of Fig. 11 #534 consists of hardware comprising any device configured to receive and/or transmit data, see paragraph 76.) and
an electronic processor coupled to the camera system and the transceiver (Camera coupled to processor via device interface/transceiver, see paragraphs 76-77.) and configured to
receive a prescription to be filled by the pharmaceutical counting and packaging device (Device receives prescription, see scanning of previously prepared prescription label of Lang, paragraphs 51-52.);
capture, using the camera system, an image of a label applied to a package receiving a first type of medication listed on the prescription (Lang discloses capturing the image of the label of a final vial receiving the medication, see paragraph 53. The Office notes that the scanning disclosed in Lang can be performed by a camera system, see paragraphs 57, 64 and 73.);
count a number of medications on the counting tray (Lang, paragraph 53.);
determine whether the number of medications on the counting tray matches the number of medications needed to fill the prescription (Lang, paragraphs 53 and 73.);
in response to the number of medications on the counting tray matching the number of medications needed to fill the prescription, capture, using the camera system, an image of medications on the counting tray… (Pursuant to the system indicating that the correct medication and correct medication count is verified, Lang discloses capturing the image of the label of a final vial receiving the medication, see paragraph 53. The Office notes that the scanning disclosed in Lang can be performed by a camera system, see paragraphs 57, 64 and 73. A previous embodiment of Lang discloses capturing images of medications on the counting tray, see paragraph 53.); and
display … the image of the label applied to the package (Lang discloses displaying the scanned label, see paragraph 53.); and
receive … verification information … wherein the verification information includes an indication of whether the package is correctly packaged (Lang, Fig. 6 #186 and paragraph 53 discloses wherein the system verifies whether the package is packaged correctly by rescanning the label in that a failed verification will result in the agent being directed to intervene, and a successful verification will result in the system continuing operations to finalize the procedure. Circuitry that controls the counter 10 can be placed remotely, see paragraph 26. The online Wiktionary dictionary defines a transceiver as “A device that performs transmitting and receiving functions, especially if using common components.” Accordingly, computers contain transceivers to communicate.).
Lang fails to explicitly disclose:
capturing an image of medications in the package;
deactivating a lockout mechanism of the counting tray in order to allow a user to lift the counting tray to fill the medications in the package,
transmit, using the transceiver, the image of the label applied to the package, the image of medications on the counting tray, and the image of medications in the package to a remote device, and
receiving data using the transceiver … from the remote device.
However, Takashima teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to disclose capturing an image of medications in a package and transmitting a relevant verified patient data to a remote device (Takashima, see Fig. 10 S54 and S68-S70.) and receiving data using the transceiver … from the remote device (Takashima discloses receiving data from the remote device, see at least Fig. 18 #S108.) in order to provide an audit system for packaged medications (See Takashima paragraph 17.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the prescription medication verification system of Lang to include capturing an image of medications in a package and transmitting a relevant verified patient data to a remote device, as taught by Takashima, in order to arrive at a prescription medication verification system that provides an audit system for packaged medications (See Takashima paragraph 17.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Neither Lang nor Takashima disclose deactivating a lockout mechanism of the counting tray in order to allow a user to lift the counting tray to fill the medications in the package.
However, Holmes teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to disclose deactivating a lockout mechanism of the counting tray in order to limit access to the medications when they should not be accessed, thereby increasing safety and reliability of the system.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the prescription medication verification system of Lang/Takashima to include deactivating a lockout mechanism of the counting tray, as taught by Holmes, in order to arrive at a prescription medication verification system that can order to limit access to the medications when they should not be accessed, thereby increasing safety and reliability of the system. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Lang, Takashima and Holmes are all directed to the electronic processing of patient healthcare data and specifically to the verification of filled prescriptions.
A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see MPEP 2114 (II) and Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). “Language that suggest or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation”, see MPEP 2111.04.
The following limitation is interpreted as an intended use of the claimed invention:
5,10. in order to allow a user to lift the counting tray to fill the medications in the package.
The prior art is capable of performing the intended use recitation, therefore the prior art meets the limitations.
As per claims 8 and 13, Lang/Takashima/Holmes disclose claims 5 and 10, discussed above. Lang also discloses:
8,13. receive verification information corresponding to the prescription, wherein the verification information includes an indication of whether the package is correctly packaged by the pharmaceutical counting and packaging device (Lang discloses transmission of an indication to prepare the device for future use based on a confirmed correct fill, see paragraph 53.).
As per claims 6, 7, 11 and 12, Lang/Takashima/Holmes disclose claims 5 and 10, discussed above. Lang also discloses verification of medications on a counting tray corresponding to a prescription, as shown above. However, Lang fails to disclose:
6,11. determine whether a second type of medication … corresponds to a third type of medication listed on the prescription;
transmit a first indication to the remote device when the second type of medication … corresponds to the third type of medication; and
transmit a second indication to the remote device when the second type of medication … does not correspond to the third type of medication; and
7,12. transmit the prescription to the remote device.
However, Takashima teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to disclose a system to determine whether a plurality of imaged medications correspond to a plurality of prescriptions for a patient, and provides a corresponding notification, see Fig. 11 and the transmission of all relevant patient data to a remote database, see Fig. 10 S70 in order to provide an audit system for packaged medications (See Takashima paragraph 17.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the prescription medication verification system of Lang/Takashima/Holmes to include determining whether a plurality of imaged medications correspond to a plurality of prescriptions for a patient, and providing a corresponding notification, and transmitting of all relevant patient data to a remote database, as taught by Takashima, in order to arrive at a prescription medication verification system that provides an audit system for packaged medications (See Takashima paragraph 17.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claims 18-23 are rejected under 35 U.S.C. 103 as being obvious over Lang/Takashima/Holmes further in view of Yokouchi et al. (U.S. PG-Pub 2020/0394786 A1), hereinafter Yokouchi.
As per claims 18-23, Lang/Takashima/Holmes discloses claims 5 and 10, as shown above. Lang also discloses:
18,21. wherein the image of medications on the counting tray is a first image of medications on the counting tray (Lang, paragraph 53.),
determine one or more characteristics of the medications on the counting tray based on the … image (Lang, system uses color and sizing to verify medications, see paragraph 37.);
compare the determined characteristics with known characteristics of an expected medication for verification during packaging (Lang, system uses color and sizing to verify medications, see paragraph 37.); and
count the number of medications on the counting tray based on the second … of medications on the counting tray (Lang, paragraph 53.);
19,22. wherein the one or more characteristics of the medication is at least one selected from a group consisting of color and dimension (Lang, system uses color and sizing to verify medications, see paragraph 37.); and
20,23. wherein the camera system includes: a first camera configured to capture the image of medications on the counting tray and the image of medications in the package from a top perspective (Lang, Fig. 1 #22 and 5 #118.).
Lang/Takashima/Holmes fails to explicitly disclose:
18,21. Capturing images with another camera; and
20,23. a second camera configured to capture the image of the label applied to the package from a side perspective.
Yokouchi teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to disclose a taking plural images with multiple cameras, including one from a side perspective (See, Yokouchi Fig. 6) in order to perform more effective medication verification (Yokouchi, paragraph 3.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the prescription medication verification system of Lang/Takashima/Holmes to include capturing data from multiple cameras at different angles, as taught by Yokouchi, in order to arrive at a prescription medication verification system that performs more effective medication verification (See Takashima paragraph 17.).
Both Lang and Yokouchi are directed to the electronic processing of patient healthcare data and specifically to the verification of filled prescriptions. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Response to Arguments
Applicant’s arguments filed 4 May 2026 concerning the rejection of all claims under 35 U.S.C. 101 have been fully considered and are persuasive.
The Applicant argues on pages 7-8 that the claims comprise statutory material because the claim language added by amendment directed to deactivating a lockout mechanism provide control of a physical process and governs operation of a physical device in a manner that integrate any alleged judicial exception into a practical application.
The Office agrees and has accordingly removed the statutory rejection.
Applicant’s arguments filed 4 May 2026 concerning the rejection of all claims under 35 U.S.C. 103 have been fully considered but they are deemed not persuasive.
Applicant argues that the references fail to disclose the language added by amendment.
Applicant's arguments have been fully considered but are moot in view of the new ground(s) of rejection, specifically with reference to the new reference necessitated by amendment, Holmes, as detailed above, or because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references, including the features newly added by amendment, have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of Lang, Takashima, Holmes, Yokouchi and Poirier, based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Action (10 March 2026, 4 December 2025 and 2 June 2025), and incorporated herein.
Conclusion
Unused but cited relevant prior art includes:
Ferguson et al. (U.S. PG-Pub 2021/0057070 A1) discloses an augmented reality pharmacy system that uses image processing to characterize prescriptions and drug information to verify fulfillment.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
17 June 2026
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