DETAILED ACTION
This is responsive to RCE filed on 11/18/2025 in which claims 1-10 and 20 are presented for examination; Claims 1 and 20 have been amended. Claims 11 -19 have been canceled.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
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 1-10 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?” Yes, it’s a process(method).
Step 2a Prong 1 (judicial exception)
Step 2A (1): “Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes , the claim comes under mental processes.
Claim 1 recites:
“A method comprising: receiving information associated with a drug product, the information comprising a plurality of characteristics and image information; filtering the received information based on at least one of the plurality of characteristics to identify one of a plurality of artificial intelligence engines, the plurality of artificial intelligence engines corresponding to a plurality of value combinations of the at least one of the plurality of characteristics; modifying one or more pixels of the image information to perform a correction thereof; predicting, using the one of the plurality of artificial intelligence engines that was identified and based on the image information that has been modified, a National Drug Code (NDC) for the drug product or verifying, using the one of the plurality of intelligence engines that was identified and based on the image information that has been modified, whether the drug product matches a target drug product; and granting an entity access to ones of the plurality of artificial intelligence engines based on the entity distributing ones of a plurality of drug products having ones of the plurality of value combinations, respectively, that correspond to the ones of the plurality of artificial intelligence engines.”
All the limitations above are abstract idea related to the mental process (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)) with the exception of bold and underlined limitations. Claim language pertains to identifying and categorizing (by extracting required data ), a drug according to the information received and specifying NDC code for it. Also, verifying the identified/categorized drug matches the correct one , can be easily done mentally or on paper.
Step 2A(2): Prong Two: evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception. NO
The claim does recite additional elements; however they don’t integrate the exception into a practical application of the exception.
receiving information(Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g) )
training artificial intelligence engines (Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
modifying one or more pixels of the image information to perform a correction thereof(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)) “ Note: Also, see the arguments addressed with regards to 101 .
intelligence engines(Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f))
Step 2B: evaluate whether the claim recites additional elements that amount to an inventive concept (aka “significantly more”) than the recited judicial exception? NO
As discussed previously with respect to Step 2A Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
Regarding the claim limitation,“ receiving information” the courts have recognized the computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information”); See, MPEP 2106.05 (d)(II)
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Dependent claims 2-10 further narrows the abstract idea and add the additional elements of “convolutional neural network”, “skip connection”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Regarding claim 20, it is rejected under the same rationale as claim 1, and adds the additional elements of “system”, “processor”, “memory”, “computer readable program code”.
Under step 2A, prong two, the additional elements don’t integrate the exception into a practical application of the exception as merely adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f).
As discussed previously with respect to Step 2A Prong Two, the additional elements in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Response to Arguments
Applicant's arguments filed on 11/18/2025 have been fully considered but they are not persuasive.
.
Remarks - 35 USC § 101
In remarks, Pg. 4, applicant contends:
“Applicant submits that modifying one or more pixels of image information to perform a correction thereof and using the modified image information to predict an NDC of the drug product or verify that the drug product matches a target drug product as recited in independent Claims 1 and 20 are of the level of complexity that they cannot be reasonably or practically performed in the human mind. MPEP 2106.04(a)(2)(III)(A) states that "a claim to a specific data encryption method for computer communication involving a several-step manipulation of data" cannot be practically performed in the human mind.”
The image modification does not relate to case fact of specific data encryption involving several step of manipulation of data. In addition, image pixel can be modified by simply adding further detail or erasing a portion of the image using paper and pen. Also, in the context of claim, the image processing technique to modify the image pixel is being used, which is usually done via the computer. In the instance case, even if we don’t treat image modification as abstract idea, and treat as additional limitation; the step merely applies image processing technology and does not integrate the abstract idea into practical application. Furthermore, even if one treats modifying image pixel to be more than “just apply” (just an assumption), it will be insignificant extra-solution activity. The image processing and manipulation is well understood and conventional. For example, Kumar et al. (US 20190057486 A1) discloses “[0055] The visualization circuit 612 can be configured to modify or manipulate a plurality of pixel values in the pixel matrix to virtually rotate the visualization using any conventional or suitable image processing techniques. In some embodiments, the visualization circuit 612 can be configured to initially receive digital pixel data relating to the pixel matrix. The received pixel data can correspond to a pixel matrix that visually represents an unmodified visualization (e.g., the visualization 250 as shown with reference to FIG. 2)….”
In remarks, Pg. 6, applicant contends: “according to independent Claims 1 and 20, as amended, the information associated with the drug product includes image information and one or more pixels of the image information are modified to perform a correction thereof. Correcting the pixels of an image to create a modified image transforms the image to a different state, i.e., a corrected state, which is akin to the example of "[e]effecting a transformation or reduction of a particular article to a different state or thing" as set forth in the MPEP.”
Please see explanation with regard to previous argument above; the claim simply applies image manipulation technique, and the claims or specification don’t disclose any technical improvement to the image manipulation technique.
Remarks - 35 USC § 102
The applicant’s amendments to independent claims include the allowable subject matter, and overcome the prior arts of record; thus the prior art rejection have been withdrawn.
Conclusion
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/HUMA WASEEM/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686