DETAILED ACTION
This is responsive to amendments filed on 12/31/2025 in which claims 1-11 are presented for examination; Claims 1 and 11 have been amended.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, and 11, the amended claims recite “generating, based on the grade and type of the side effect of the pair of drugs, a control signal for controlling a device to perform prediction operation according to the DDI, at the processor.”
The specification doesn’t disclose the above amended claim language, specifically generating the control signal based on grade and type of side effect to control the device. The cited paras 0043-0044 don’t have any such disclosure, in fact the instant specification mentions term control only at para 0047, 0048, and 0111 (control/controller), however not in the claimed context; furthermore the term signal is only mentioned in para 0104, and 0111 in generic manner.
Dependent claims 2-10 don’t present any information regarding the issue in independent claims, thus carry same issue.
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 1-11 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 method(process).
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 of analyzing drug-drug interaction (DDI), the method comprising: acquiring a first data set for chemical structures of drugs, a second data set for a grade of a side effect between the drugs and a third data set for a type of a side effect between the drugs, as data sets for training, at a processor configured to analyze the DDI; generating detailed attribute information of each of the drugs, by preprocessing the first data set, at the processor; standardizing a class included in the second data set and giving directionality, by preprocessing the second data set, at the processor; extracting expressions representing a side effect type included in the third data set, normalizing the expressions and giving directionality to the third data set, by preprocessing the third data set, at the processor; training at least one artificial intelligence model stored in a memory using the preprocessed first data set, the preprocessed second data set and the preprocessed third data set, at the processor; determining the grade and type of the side effect of a pair of drugs from information on the pair of drugs using the at least one artificial intelligence model, at the processor. And generating, based on the grade and type of the side effect of the pair of drugs, a control signal for controlling a device to perform prediction operation according to the DDI, at the processor.”
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 analyzing interaction between drugs, based on their chemical structures and side effects. Based on the data , one can analyze, using paper and pen , the drug side effects and severity/grade of drug interaction.
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.
acquiring a first dataset(Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g) )
data sets for training (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))
processor (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))
training(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))
artificial intelligence model( 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))
memory( 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))
control signal (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g) )
device( 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,“ acquiring a first dataset 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 similar can be said about control signal, as here the control signal is merely transmitting the instruction to perform the prediction. There are ample, example of using the machine learning to perform the prediction, in fact that is what the machine learning is used for to train the model, and use the model to make prediction. For further evidence, please see term “prediction” in the context of machine learning.
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 “transmitting data” “device”.
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).
Regarding limitation “transmitting data” (Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g) ) 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)
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 11, it is rejected under the same rationale as claim 11. In addition the claim adds the additional elements of “device”, “memory”, “artificial intelligence model”, “processor”, “control signal”, “device” .
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.
Response to Arguments
Applicant's arguments filed on 15 have been fully considered but they are not persuasive.
Remarks - 35 USC § 101
In remarks, Pg. 10, applicant contends: “Claim 1 recites "[a] method of analyzing drug-drug interaction (DDI)," and Claim 11 recites "[a] device for analyzing drug-drug interaction (DDI)." Emphasis added. The claimed invention has a hardware such as "processor," "device," and "memory" as the Office- provided examples that do not to recite a judicial exception under Prong One test under Step 2A.”
The examiner have addressed these elements as additional elements, thus not considered as abstract idea.
In remarks, Pg. 14, applicant contends: “it is noted that Example 49 and the claimed invention are similar to the extent that they involve personalized medical treatment providing a practical application; Claim 1, as amended, recites "generating, based on the grade and type of the side effect of the pair of drugs, a control signal for controlling a device to perform prediction operation according to the DDI, at the processor." Emphasis added. The additional elements recited in Claim 1 is a particular operation of a processor to "generat[e], based on the grade and type of the side effect of the pair of drugs, a control signal for controlling a device to perform prediction operation according to the DDI."
As recited above in the amended claim language, the signal is to perform the prediction operation, not administration of particular treatment as pointed in the example 49. In addition, please see 112(a) rejection above, with regard to amended claim language.
For further remarks, please see updated 35 U.S.C 101 rejection above, as it addresses the amended claim language. Also, applicant seems to be discussing the generic hardware elements to argue that claims don’t represent the abstract idea. Having generic elements that are used as tool to execute the abstract idea does not ensure that claim language doesn’t fall within one of the abstract idea grouping; 35 U.S.C 101 is step wise analysis, where the abstract idea and additional elements are identified; and then identified additional elements are evaluated to see whether the additional elements integrate the abstract idea into practical application. The claims or specification don’t provide any detail that would show an improvement to a processor, memory, or machine learning technology. Furthermore. The examiner have identified “acquiring a first dataset”, especially over the network to be insignificant extra-solution activity; and this element doesn’t provide an inventive concept, as “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)” is recognized by the courts to have the computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner.
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 concerning this communication or earlier communications from the examiner should be directed to HUMA WASEEM whose telephone number is (571)272-1316. The examiner can normally be reached Monday-Friday(9:00am - 5:00 pm) EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason B. Dunham can be reached on (571) 272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HUMA WASEEM/Examiner, Art Unit 3686
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686