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 .
Priority
Acknowledgement is made of Applicant’s claim of priority based on continuation-in-part to U.S. Application No. 17/330,803, filed of May 26, 2021, now U.S. Patent No. 12,027,247, and U.S. Application No. 17/330,813, filed of May 26, 2021, now U.S. Patent No. 12,580,061, which claim priority to U.S. Provisional Application No. 63,032,328, filed May 29, 2020.
Information Disclosure Statement
The information disclosure statements (“IDS”) filed on 04/01/2024, 07/09/2024, 09/24/2024, 02/20/2025, and 11/20/2025 were reviewed and the listed references were noted.
Drawings
The 41 page drawings have been considered and placed on record in the file.
Status of Claims
Claims 1-21 are pending.
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 1-5, 7-8, 10-14, 16-17, and 19-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (an abstract idea without significantly more). The claims recite a method, system, and computer-readable medium for processing a prescription product to be dispensed through image analysis. With respect to analysis of method recited in method Claim 1:
Step 1:
With regard to Step 1, the instant claim is directed to a method; and therefore, the claim is directed to one of the statutory categories of inventions.
Step 2A, Prong One:
With regard to 2A, Prong One, the limitations “processing the image with an or a pharmacist may receive an image of the prescription product, generate a condition signal, such as reject the image if unacceptable, and require a new image, as a further action. This is the concept that falls under the groupings of abstract ideas of mental processes, i.e., a concept perform in the human mind, evaluation, judgement, and/or opinion of a technician/pharmacist.
Step 2A, Prong Two:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception. In the instant case, the additional steps/elements in the claim are “receiving an image of a prescription product to be dispensed according to a prescription to a patient” regarded as insignificant extra-solution activities, such as acquiring image data. This is regarded as adding insignificant steps to perform the judicial exception, and do not apply, rely on, or use the judicial exception as an indication of integration of the judicial exception into a practical application. Accordingly, the above-mentioned additional element/limitation does not integrate the abstract idea into a practical application; and therefore, the claims recite an abstract idea.
Step 2B:
Because the claims fail under Step 2A, the claims are further evaluated under Step 2B. The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because as discussed above with respect to integration of the abstract idea into practical application, the additional elements/limitations to perform the steps, amount to no more than insignificant extra-solution activities of acquiring image data. Finally, the recited “an artificial intelligence model”, “a memory”, and “a processor” are simply regarded as generic computer component, which are insignificant addition elements. Therefore, independent Claims 1, 11, and 21 are not patent eligible.
Furthermore, with regard to dependent Claims 2-5, 7-8, 10, 12-14, 16-17, and 19-20 viewed individually, these additional steps, under their broadest reasonable interpretation, provide extra-solution activities to cover performance of the limitations as an abstract idea, and do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Accordingly, they are not patent eligible.
Finally, the limitations recited in Claims 6, 9, 15, and 18 are considered to either be significantly more than the abstract idea, or integrate the identified abstract idea into a practical application. Therefore, these claims are not rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-27 and 29-41 are rejected under 35 U.S.C. 103 as being unpatentable over Jhaveri et al. (US 11,581,079 - IDS) in view of Jacobs et al. (US 2018/0225818).
Consider Claim 1, Jhaveri discloses “A computer-implemented method comprising: receiving an image of a prescription product to be dispensed according to a prescription to a patient” (Jhaveri, Abstract, Fig. 5, and Column 5, lines 36-38 and lines 55-57); “processing the image (Jhaveri, Column 9, Lines 37-38, wherein it is disclosed if the condition images are not acceptable, the pharmacist reject the prescription); “sending the condition signal to an image analysis engine” (Jhaveri, Fig. 20, and Column 9, lines 39-41, the image analysis engine is interpreted to be the pharmacist revieing the image of the prescription); and responsive to receiving the condition signal, performing an action based on the prescription product condition” (Jhaveri, Column 9, lines 41-48, where rejection of the prescription by the pharmacist is being disclosed as an action; and Jhaveri, Column 9, lines 49-60 disclose the further action would be the instructions to the technician to refill the prescription and re-scanning the prescription). Although Jhaveri discloses its method to be image based and network controlled wherein visual confirmation is based on automated confirmation (for example, Jhaveri, Claim 3); Jhaveri is not relied on to disclose “processing the image with an artificial intelligence model”. In an analogous field of endeavor, Jacobs discloses a pill verification system that “processes the feature vectors using at least one classifier trained on a database of pill images and associated pill types. As a result of the classification, the pill verification system 120 determines a pill type for the pill and whether the pill type matches the prescription information, including whether it is the correct type of pill and whether it is the correct dosage as stated in the prescription information” (Jacobs, Paragraph [0016]).
Accordingly, before the effective date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Jhaveri with teachings of Jacobs to use an artificial intelligence system to process images of the prescription products. One of ordinary skill in the art would be motivated to combine the above-described references to create a robust and automated system for verification of dispensing the correct prescription products to consumers and reduce the human error. Therefore, it would have been obvious to combine Jhaveri and Jacobs to obtain the invention of Claim 1.
Consider Claim 2, the combination of Jhaveri and Jacobs discloses “The computer-implemented method of claim 1, wherein the image comprises a pill counting tray, and the prescription product is one or more pills” (Jhaveri, Figs. 9 and 17A and B).
Consider Claim 3, the combination of Jhaveri and Jacobs discloses “The computer-implemented method of claim 1, wherein the prescription product condition is a number of pills in the image, and the condition signal comprises a numerical value of a pill count” (Jhaveri, Figs. 17A and B and Column 8, lines 17-19, the automated counting of the pills).
Consider Claim 4, the combination of Jhaveri and Jacobs discloses “The computer-implemented method of claim 1, wherein the prescription product condition is one from a group of: image quality, image brightness, image blur, image focus, number of pills, types of pills in the image, co-mingling of two or more different pill types in the image, a broken pill, pill residue, non-pill object presence, strip presence, pill bottle presence, stacked pills, watermark, tamper condition, pill cut, and therapeutic classification” (emphasis added) (Jhaveri, Column 9, lines 43-48).
Consider Claim 5, the combination of Jhaveri and Jacobs discloses “The computer-implemented method of claim 1, wherein the artificial intelligence model is one from a group of: a neural network, a convolutional neural network, a random forest algorithm, a classifier, a You Only Look Once model, geometric systems, nearest neighbors and support vector machines, probabilistic systems, evolutionary systems, genetic algorithms, decision trees, Bayesian inference, boosting, logistic regression, faceted navigation, query refinement, query expansion, singular value decomposition, and a Markov chain” (emphasis added) (Jacobs, Paragraph [0016], the classifier). The proposed combination as well as the motivation for combining the Jhaveri and Jacobs references presented in the rejection of Claim 1, apply to Claim 5 and are incorporated herein by reference. Thus, the method recited in Claim 5 is met by Jhaveri and Jacobs.
Consider Claim 7, the combination of Jhaveri and Jacobs discloses “The computer-implemented method of claim 1, further comprising generating an image annotation, wherein generating the image annotation comprises: retrieving the image; determining a portion of the received image to annotate; generating an annotation based upon the prescription product condition; combining the annotation with the received image to produce an annotated image; and providing the annotated image for presentation to a user” (Jhaveri, Column 10, lines 21-25, the labeling process of the prescription products to be imaged).
Consider Claim 8, the combination of Jhaveri and Jacobs discloses “The computer-implemented method of claim 1, further comprising: performing optical character recognition on the image to generate recognized text; sending the recognized text to the image analysis engine; and wherein the action is determined in part based upon the recognized text” (Jhaveri, Column 6, lines 45-52, performing the optical character recognition of the prescription and storing the images).
Consider Claim 10, the combination of Jhaveri and Jacobs discloses “The computer-implemented method of claim 1, wherein the action is one from a group of: generating and sending a warning signal; generating and sending the warning signal including the prescription product condition; generating and sending a signal including a number of pills detected in the image; generating an annotated image and presenting the annotated image for display; generating an indication that the image of the prescription product is unacceptable and sending a recapture signal to prompt capture of another image to replace the image; generating the indication that the image of the prescription product is unacceptable and automatically recapturing another image to replace the image; and storing a copy of the image” (emphasis added) (Jhaveri, Column 9, lines 37-47, when in case of poor condition of the image, a rejection signal is generated).
Claims 11 and 20 recite systems with elements corresponding to the steps of the methods recited in Claims 1 and 2, respectively. Therefore, the recited elements of these claims are mapped to the proposed combination in the same manner as the corresponding steps in their corresponding method claims. Additionally, the rationale and motivation to combine the Jhaveri and Jacobs references, presented in rejection of Claim 1, apply to these claims. Finally, the combination of Jhaveri and Jacobs discloses a memory and a processor (Jhaveri, Fig. 2:60 and Column 3, lines 55-60).
Claims 12-14 recite systems with elements corresponding to the steps of the methods recited in Claims 3-10, respectively. Therefore, the recited elements of these claims are mapped to the proposed combination in the same manner as the corresponding steps in their corresponding method claims. Additionally, the rationale and motivation to combine the Jhaveri and Jacobs references, presented in rejection of Claim 1, apply to these claims. Finally, the combination of Jhaveri and Jacobs discloses a memory and a processor (Jhaveri, Fig. 2:60 and Column 3, lines 55-60).
Claim 21 recites a non-transitory computer-readable medium storing computer instructions corresponding to the steps of the method recited in Claim 1. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding method claim. Additionally, the rationale and motivation to combine the Jhaveri and Jacobs references, presented in rejection of Claim 1, apply to this claim. Finally, the combination of Jhaveri and Jacobs discloses a memory (Jhaveri, Fig. 2:60 and Column 3, lines 55-60).
Allowable Subject Matter
Claims 6, 9, 15, and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: none of the cited prior art references, alone or in combination, provides a motivation to teach the ordered combination of limitations recited in these dependent claims and the claims they depend from.
Conclusion and Contact
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure: Shorten et al. (US 2022/0301665).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Siamak HARANDI whose telephone number is (571)270-1832. The examiner can normally be reached on Monday - Friday 9:30 - 6:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amandeep Saini can be reached on (571)272-3382. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Siamak Harandi/Primary Examiner, Art Unit 2662
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