DETAILED ACTION
Status
This Final Office Action is in response to the communication filed on 23 July 2025. Claims 6-7 have been cancelled, claims 1-5 have been amended, and no new claims have been added. Therefore, claims 1-5 are pending and presented for examination.
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 .
Response to Amendment
A summary of the Examiner’s Response to Applicant’s amendment:
Applicant’s amendment overcomes the issues and rejection(s) under 35 USC § 112; therefore, the Examiner withdraws the rejection(s).
Applicant’s amendment appears to overcome the § 101 rejection(s) related to a statutory category or classification; therefore, the Examiner withdraws these rejection(s).
Applicant’s amendment does not overcome the abstract idea rejection(s) under 35 USC § 101; therefore, the Examiner maintains the rejection(s) while updating phrasing in keeping with current examination guidelines.
Applicant’s amendment does not overcome the prior art rejection(s) under 35 USC §§ 102 or 103; therefore, the Examiner maintains the rejection(s) as below.
Applicant’s arguments are found to be not persuasive; please see the Response to Arguments below.
Claim Objections
Claim 1 is objected to because of the following informalities: the term “Storing” at the first element should not be capitalized. Appropriate correction is required.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a method (claims 1-4) and non-transitory computer-readable information recording medium (claim 5), which may be amended to indicate being classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites an information provision method executed by a computer system including a processor and a memory, comprising: storing, in the memory, medicine information including a name of a medicine and information on a country where the medicine is pharmaceutically approved for each of medicines; receiving import medicine information including a name of a medicine desired to be imported and a country to which the medicine is desired to be imported; automatically reading the medicine information on one medicine from the memory; receiving the name of the medicine and the country to which the medicine is desired to be imported, which are input from a terminal of a user; determining, by the processor, whether the country to which the medicine is desired to be imported is included in a list of pharmaceutically approved countries for the medicine; and in response to the determination, automatically outputting approval information as information on whether or not the one medicine is pharmaceutically approved in the country to which the one medicine is desired to be imported when the import medicine information on the one medicine is input from the terminal of a user.
Independent claim 5 recites a non-transitory computer-readable information recording medium that stores a program, wherein when the program is executed, it performs the same functions as at claim 1, and is therefore analyzed in the same manner as claim 1 above.
Independent claim 7 is also analyzed in the same manner as claim 1 since directed to a method of performing the same or similar activities as at claim 1 above.
The dependent claims (claims 2-4 and 6) appear to be encompassed by the abstract idea of the independent claims since they merely indicate issuing an alert when a medicine is not approved in a country for which importing is desired (claim 2), the information that is included, read, used, and/or output (claims 3 and 4) and/or a computer-readable medium for storing the program (claim 6).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of storing information and using that information to identify whether a medicine is approved for use in a country; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Certain methods of organizing human activity (e.g. fundamental economic principles or practices such as hedging, insurance, mitigating risk; commercial or legal interactions such as agreements, contracts, legal obligations, advertising, marketing or sales activities/behaviors, or business relations; and/or managing personal behavior or relationships between people such as social activities, teaching, and following rules or instructions) based at least on the business and personal relations regarding medicine approval; and
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) based at least on being able to store, lookup, retrieve, and use the approval information either mentally alone, or with the use of pen/pencil and paper.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are merely the method being performed by a computer system including a processor and a memory, storing in the memory, performing activities by the processor (at claim 1), and use of a non-transitory computer-readable information recording medium that stores a program (at claim 5). These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant ¶ 0016 as submitted (0026 as published) appears to be the most relevant description and only indicates the computers as being general-purpose or generic computers, i.e., a server and client such as a mobile terminal and a desktop personal computer.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
NOTICE
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.
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 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (U.S. Patent Application Publication No. 2020/0134551) in view of Dai (U.S. Patent Application Publication No. 2021/0210213) .
Claim 1: Singh discloses method executed by a computer system including a processor and a memory (see Singh at least at, e.g., ¶ 0006, “The system for facilitating international trade comprising a server including a processor and a memory in communication with the processor”), comprising:
storing, in the memory medicine information including a name of a medicine and information on a country where the medicine is approved for each of medicines (0412, “The system stores trade information for it to be easily accessible by importers and exporters”, 0414, “The system contains member-nation's requirements for the select good(s) in the customs tariff of select member nations, this information is accessible and published under the public domain of member-nations, titled as ‘importing (select good) into a (select nation),’ can be searched on the worldwide web, and a process map, of ‘how-to’ import can be created with research and developmental support”, 0205 indicating that this includes “Exchange of information concerning illicit traffic in narcotic drugs”; citation hereafter by number only);
receiving import medicine information including … a medicine desired to be imported and a country to which the medicine is desired to be imported (0412, 0414, as above);
automatically reading out the medicine information on one medicine from the memory (0100, “The system processes this information into an internal database for purposes of handling a request for quotation, and proposal for logistics service; when, the request(s) for quotation are received, they are filtered according to the criteria of the set inquiry by the user, and the fields of inquiry, are then automated, to match the logistics service providers; and then, complied to be transferred into a formal request for quotation, provided to the user”, 0412, 0414, 0205 as above);
receiving the name of the medicine and the country to which the medicine is desired to be imported, which are input from a terminal of a user (0098, “The system processes the origin and destination service request(s) by route planning and coordinating the mode(s) of transportation that fit-into the origin and destination the system services”, 0100, “The system processes this information into an internal database for purposes of handling a request for quotation, and proposal for logistics service; when, the request(s) for quotation are received, they are filtered according to the criteria of the set inquiry by the user, and the fields of inquiry, are then automated, to match the logistics service providers; and then, complied to be transferred into a formal request for quotation, provided to the user”, 0412, 0414, 0205 as above);
determining, by the processor, whether the country to which the medicine is desired to be imported is included in a list of pharmaceutically approved countries for the medicine (0010, “The method may further include the steps of: receiving at the server an agency-approval; generating an agency-approval file; sending the agency-approval file to the appropriate customs-broker; receiving at the sever a release-request; generating a release-request file; storing the release-request file on the database; and sending the release-request file to the trade-company profile”, 0205 as above; and
in response to the determination, automatically outputting approval information as information on whether or not the one medicine is pharmaceutically approved in the country to which the one medicine is desired to be imported when the import medicine information on the one medicine is input from the terminal of a user (0412, 0414, as above).
Where it appears that to search for import rules regarding a medicine or drug as indicated by Singh, the name of the medicine or drug would be required, Singh does not appear to explicitly disclose this level of detail. However, Dai teaches that “outputting the target recommended medicine includes” (Dai at 0031), including “collecting medicine data, the medicine data including names of medicines, names of diseases to which the medicines apply” (Dai at 0034 – indicating the target disease as at Dai 0123-0124), “generating the preset medicine knowledge graph by determining a data triplet of “entity-relationship-entity” in which the names of diseases in the medicine data serve as a starting point, and the names of medicines corresponding to the starting point and the precautions for usage of the medicines are associated with the starting point” (Dai at 0035), where someone can “perform medicine filtering through related information search in the medicine knowledge graph” (Dai at 0044). Therefore, the base system and/or methods of product searching as in Singh would be predictably improved or modified by the name identification of drugs and target disease indicated in Dai so as to yield the predictable result of naming the particular medicine so as to enable a look up of the specific information of a particular medicine. As such, the Examiner understands and finds that to include a name in the import medicine information is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to enable a look up of the specific information of a particular medicine.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine or modify the searching of Singh with the medicine and disease identification of Dai in order to include a name in the import medicine information so as to enable a look up of the specific information of a particular medicine.
The rationale for combining in this manner is that to include a name in the import medicine information is applying a known technique to a known device, method, or product ready for improvement to yield predictable results so as to enable a look up of the specific information of a particular medicine as explained above.
Claim 2: Singh in view of Dai discloses the information provision system (1) according to claim 1, wherein the approval information output means (7) issues an alert when the one medicine is not approved in a country to which the one medicine is desired to be imported (Singh at 0412, 0414, as above; Dai at 0042-0043, outputting unrecommended medicine information and the reason for non-recommendation, as combined above and using the rationale as at the combination above).
Claim 3: Singh in view of Dai discloses the information provision system (1) according to claim 1, wherein the medicine information further includes information on a target disease for each of the medicines, and the information provision system (1) further comprises target disease related medicine information output means (9) that reads out information on the target disease related to the one medicine from the medicine information storage means (3) using the information on the target disease, reads out a name of a medicine related to the target disease from the medicine information storage means (3), and outputs the read name of the medicine as a medicine related to the one medicine (Dai 0031, 0034-0035, 0042-0044, 0123-0124, as combined above and using the rationale as at the combination above
Claim 4: Singh in view of Dai discloses the information provision system (1) according to claim 1, wherein the medicine information further includes information on an active ingredient for each of the medicines, and the information provision system (1) further comprises same active ingredient medicine information output means (11) that reads out information on the active ingredient related to the one medicine from the medicine information storage means (3) using the information on the active ingredient, reads out a name of a medicine including the active ingredient from the medicine information storage means (3), and outputs the read name of the medicine as a medicine having the same active ingredient as the one medicine (Dai at 0112, “the medicine knowledge graph constructed in the above manner includes … information such as product ingredients”, as combined above and using the rationale as at the combination above).
Claim 5 is rejected on the same basis as claim 1 above since Singh in view of Dai discloses a non-transitory computer-readable information recording medium that stores a program, wherein when the program is executed, it performs the same or similar activities as at claim 1 (Singh at 0638-0640, the computer requiring a program to perform the activities, and Dai at 0160-0161, as combined above and using the rationale as at the combination above).
Response to Arguments
Applicant's arguments filed 23 July 2025 have been fully considered but they are not persuasive.
Applicant first argues the 112(b) rejections (as based on “means” claiming under 112(f)) (Remarks at 5); however, Applicant’s amendment overcomes the rejection(s). Therefore, the argument is considered moot and not persuasive.
Applicant then argues the 101 rejection (Remarks at 5-6), first in relation to the statutory categories (Id.); however, Applicant’s amendment overcomes the rejection(s). Therefore, the argument is considered moot and not persuasive.
Applicant then argues the 101 in relation to the abstract idea analysis (Id. at 6), only alleging that the claims transform to a practical application based on the determining a desired import country is in a list of approved countries and outputting approval information as “a concrete and tangible result” (Id.) However, those activities are part of the abstract idea of storing information and using that information to identify whether a medicine is approved for use in a country. It is elements that are additional to the abstract idea that can transform to a practical application, not the abstract idea itself.
Applicant then argues the prior art (Id. at 6-8), acknowledging that Singh discloses “ensuring compliance with the legal requisites for import and export” (Id. at 7), but that this is somehow different than “pharmaceutical approval” (Id.) since “Generally, pharmaceutical approval status is a distinct regulatory domain governed by specialized agencies” (Id.). However, the only, single indication of anything related to pharmacy, pharmaceuticals, or other derivations of those terms is Applicant ¶ 0019 (as submitted, 0030 as published) indicating that “An approved country means a country where each medicine is pharmaceutically approved”.
There is no description or indication that pharmaceutical approval is any different than any “legal requisites for import and export”, what any pharmaceutical approval entails or requires, what agency or agencies would provide any approval, or even why there may be any alleged difference. The claims recite “storing … medicine information including … information on a country where the medicine is pharmaceutically approved for each of medicines”, receiving import medicine name and reading the information from the memory, and determining … whether the country to which the medicine is desired to be imported is included in a list of pharmaceutically approved countries for the medicine”. Therefore, the claims encompass approval for any and all countries on Earth, not just the United States any other particular country/countries. As such, even if some (or many) countries have very specific and/or stringent pharmaceutical approval requirements or processes, the claim breadth is not limited to those requirements. Whether there are some requirements somewhere for pharmaceutical approval that are different from legal requisites for import and export, unless or until Applicant can somehow show that these requirements for pharmaceutical approval are universally accepted and required for all countries, it appears that Applicant’s argument is adding new subject matter to the specification and then attempting to also read limitations related to that new subject matter (i.e., pharmaceutical approval being different than legal requisites) into the claims.
The Examiner notes that MPEP § 2111.01(II) indicates that it is improper to import claim limitations from the specification.
The Examiner further notes that Swartz, as indicated a pertinent prior art, apparently indicates that regulatory approval may be regarded as being the same as, or essentially the same as, pharmaceutical approval.
Therefore, the Examiner is not persuaded by Applicant’s argument(s).
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bojorquez et al. (U.S. Patent Application Publication No. 2016/0357919, hereinafter Bojorquez) discusses “Context drug lists may also be searched by a user…. A user may enter the name of a context drug list into the tab to see if any drug lists match the criteria. The user may select one of the drug lists, and then enter a search name and select a category to search for specific drugs” (Bojorquez at 0050), where “reports may be generated regarding Formulary identifiers, NCDs, Label Names, Coverages, drug alternatives, or any combination. Analytic Reports may be generated for formularies. Audit reports may be generated to show creation, sign-off/confirmation, approval, change, deletion, relationship change, imports, and exports, or any combination thereof for a formulary, context drug list, or other type of file maintained by the system” (Bojorquez at 0060).
PMDA (the Pharmaceuticals and Medical Device Agency, from Japan) List of Approved Products, downloaded from https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html on 19 April 2025, indicating a list of approved products from back to April 2004.
Swartz et al. (U.S. Patent No. 6,236,994, hereinafter Swartz) is to a “Method And Apparatus For The Integration Of Information And Knowledge” (Swartz at Title), where “The following description characterizes an embodiment of the present invention in the context of a pharmaceutical approval process” (Swartz at column:line 7:8-10), “consider a pharmaceutical research company that has initiated a large, international clinical study. The study protocol, that defines the conduct of the study (for a new chemical entity), was written by study clinicians (M.D.s). Four years and several millions of dollars later, the statistical analysis failed to support the argument for regulatory application approval. The irony is that the drug was known to be safe and effective. The failure was totally due to a faulty protocol design” (Swartz at 7:16-24), “The data are collected and put through complex statistical analyses which are interpreted and reported as analytical data by industry experts to meet stringent government requirements for regulatory application and approval…. The dichotomy existing in both the information sources and work groups jeopardizes the common goal of regulatory approval” (Swartz at 8:13-25), and “the DataDocket phase automates the process of transferring data analysis reports to a document management system for document production (e.g., regulatory approval submission)” (Swartz at 8:50-53) – apparently indicates that regulatory approval is, essentially is, or can be regarded as, synonymous with pharmaceutical approval.
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685
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