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 response filed 23 February 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, 10 and 22 have been amended.
Claims 5-8, 10-13 and 18-23 are currently pending and have been examined.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5-8, 10-13 and 18-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 5-8, 10-13 and 18-23 are within the four statutory categories. Claims 5-7 and 18-20 are drawn to a pharmaceutical counting and packaging device, which is within the four statutory categories (i.e. machine). Claims 10-13 and 21-23 are drawn to a method for remote verification for a pharmaceutical counting and packaging device, which is within the four statutory categories (i.e. process).
Prong 1 of Step 2A
Claim 5 recites: A pharmaceutical counting and packaging device comprising:
a counting tray configured to receive medications for counting;
a camera system for capturing images;
a transceiver; and
an electronic processor coupled to the camera system and the transceiver and configured to receive a prescription to be filled by the pharmaceutical counting and packaging device;
capture, using the camera system, an image of a label applied to a package receiving a first type of medication listed on the prescription;
count a number of medications on the counting tray;
determine whether the number of medications on the counting tray matches the number of medications needed to fill the prescription;
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, and capture, using the camera system, an image of medications in the package; and
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
receive, using the transceiver, verification information from the remote device, wherein the verification information includes an indication of whether the package is correctly packaged.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a mental process and/or a certain method of organizing human activity because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions – in this case, the steps of counting medications, determining whether the counted number matches the label, etc.), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for claim 10 ais identical as the abstract idea for claim 5, because the only difference between claim 5 and 10 is that claim 5 recites a device, whereas claim 10 recites a method.
Dependent claims 6-8, 11-13 and 18-23 include other limitations, for example claims 6, 11 and 18-23 further compares medications or characteristics of images, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 6-8, 11-13 and 18-23 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 6-8, 11-13 and 18-23 are nonetheless directed towards fundamentally the same abstract idea as independent claims 5 and 10.
Prong 2 of Step 2A
Claims 5-8, 10-13 and 18-23 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the tray, the package, the transceiver, the camera system and processor, which are all generically claimed and amount to merely invoking generic devices as a tool to perform the abstract idea, e.g. see paragraphs 30-33, 40 and 45 of the present Specification, see MPEP 2106.05(f); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 6-8, 11-13 and 18-23 include other limitations, but these limitations also amount to no more than generally linking the abstract idea to a particular technological environment or field of use (e.g. the recitation of cameras in claims 20 and 23), and/or adds insignificant extrasolution activity to the abstract idea (the transmission and reception of data in claims 6-8, 11-13 and 18-23), and hence do not include any additional elements beyond those already recited in independent claims 5 and 10, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 5-8, 10-13 and 18-23 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the tray, the package, the transceiver, the camera system and processor), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs 30-33, 40 and 45 of the Specification discloses that the additional elements (i.e. the tray, the package, the transceiver, the camera system and processor) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data, capture data, hold items) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives usage data, processes the usage data, and transmits a command to the dispensing device based on the processed usage data to the dispensing device over a network, for example the Internet, e.g. see paragraph [0042] of the present Specification.
Dependent claims 6-8, 11-13 and 18-23 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 5 and 10, and/or the additional elements recited in the aforementioned dependent claims similarly amount to generally linking the abstract idea to a particular technological environment or field of use (e.g. the recitation of cameras in claims 20 and 23) and/or adds insignificant extrasolution activity to the abstract idea (the transmission and reception of data in claims 6-8, 11-13 and 18-23), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 5-8, 10-13 and 18-23 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
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;
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.).
Both Lang and Takashima 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).
As per claims 8 and 13, Lang/Takashima discloses 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 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 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 further in view of Yokouchi et al. (U.S. PG-Pub 2020/0394786 A1), hereinafter Yokouchi.
As per claims 18-23, Lang/Takashima discloses claims 5 and 10, as shown above. Lang/Takashima 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 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 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 23 February 2026 concerning the rejection of claim 35 under 35 U.S.C. 112(b) have been fully considered and are persuasive in view of the amendments to the claims. Accordingly, the rejection has been withdrawn.
Applicant’s arguments filed 23 February 2026 concerning the rejection of all claims under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The Applicant argues on pages 7-11 that claims 5 and 10 were incorrectly given a statutory rejection because:
A. Step 2A, Prong 1: the claims are not directed to a mental process;
B. Step 2A, prong 2: the claims recite a specific improvement to a particular machine, and therefore integrates any judicial exception into a practical application, said specific improvement comprising package verification.
C. Step 2B: the claims recite additional elements that amount to significantly more because the system transmits image data remotely.
The Office respectfully disagrees. Please see the statutory rejection, issued above, wherein the claims are shown to be directed to an abstract idea without significantly more.
Regarding A., the claims are directed to a mental process and/or certain methods of organizing human activity because they recite various mental processes (such as a user looking at a label, etc. in order to capture a mental image thereof), or they provide observations, evaluations, judgments, and/or opinions – in this case, the steps of counting medications, determining whether the counted number matches the label. Merely reciting hardware generically does not make a claim statutory.
MPEP 2106. 04(a)(2)(Ill)(A) states that a claimed invention is directed to a mental process if the identified claim elements contain limitations that the human mind is equipped to perform. Abstract ideas that have been held to be practically performable in the human mind include collection/analysis of data, collection/comparison of data, and identifying/applying hair designs. The Office submits that Applicant's claims fall within the mental process grouping of abstract ideas and the Applicant has not identified anything in the claim invention that cannot be practically performed in the human mind. For instance, the human mind can capture images. Because the identified features of the claim can be practically performed in the human mind, the claims are directed to an abstract idea.
MPEP 2106. 04(a)(2)(11) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Office submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to verify a prescription fill. Furthermore, the Office submits that healthcare itself is inherently represents the organization of human activity. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a series of rules or instructions that a person or persons would follow to verify a prescription fill, the claimed invention is directed to an abstract idea.
Regarding B., MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, while Applicant’s argued problem is a technical problem, there is no nexus between the argued problem and the argued solution because there is no indication that the claimed invention actually solves this problem. The Applicant has identified that there is a technical problem relating to verifying prescriptions; however, there is no indication that the claim actually solves this problem. Because the claim does not explicitly solve this technical problem, a practical application is not present.
Regarding C., MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, while Applicant’s argued problem is a technical problem, there is no nexus between the argued problem and the argued solution because there is no indication that the claimed invention actually solves this problem. The Applicant has identified that there is a technical problem relating to verifying prescriptions; however, there is no indication that the claim actually solves this problem. Because the claim does not explicitly solve this technical problem, a practical application is not present.
Applicant’s arguments filed 23 February 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.
The Office disagrees. Please see the updated Office Action, above, where Lang discloses the system communicating package verification information, and Takashima discloses communications with a remote device.
The remainder of Applicant's arguments have been fully considered but are moot 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, 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 (4 December 2025 and 2 June 2025), and incorporated herein.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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
6 March 2026