DETAILED ACTION
Applicant’s response, filed 26 September 2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 Status
Claims 1, 2, 4-8, 10, 23, 34, 40, 59, 67, 69, 97, 121, 132, 153, and 154 are pending and examined herein.
Claims 1, 2, 4-8, 10, 23, 34, 40, 59, 67, 69, 97, 121, 132, 153, and 154 are rejected.
Priority
Claims 1, 2, 4-8, 10, 23, 34, 40, 59, 67, 69, 97, 121, 132, 153, and 154 are granted the claim to the benefit of priority to U.S. Provisional applications 63/221371, 63/221334, 63/221358, 63/221366, 63/221367, 63/221364 filed 13 July 2021. Claims 1, 2, 4-8, 10, 23, 34, 40, 59, 67, 69, 97, 121, 153, and 154 are not given benefit to 63/091816 filed 14 October 2020 because there is no disclosure on the use of transcultural dictionaries. Claim 132 is not given benefit to 63/091816 filed 14 October 2020 because there is no disclosure on the phytomedicine analytics for research optimization at scale system. Thus, the effective filling date of claims 1, 2, 4-8, 10, 11, 17, 23, 33, 34, 40, 59, 67, 69, 97, 121, and 132 is 13 July 2021.
Specification
The objection to the disclosure for containing an embedded hyperlink and/or other form of browser-executable code in [0173] of the instant disclosure in Office action mailed 26 March 2025 is withdrawn in view of the amendment to the disclosure received 26 September 2025.
Drawings
The drawings received 26 September 2025 are objected to. Figure 15 is objected to for being labeled FIG. 15A-C which labels partial views incorrectly (they should be labeled FIG. 15A, FIG. 15B, and FIG. 15C), Figures 15B, 16, and 23C are objected to for being colored figures, and Figure 28 is objected to because the figure contains text that is illegible.
The drawings received 14 October 2021 are objected to. FIG. 14A-C, FIGs. 22A-D, FIGs. 23A-B, FIGs. 24A-C, and FIG.30A-C are objected to for being incorrectly labeled partial views.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted (Figures 15B, 16, and 23C are still in color). Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). Figures 15B, 16, and 23C are colored drawings.
The drawings are objected to because Figure 28 contains text that is illegible, Figure 14 reads FIG. 14A-C, Figure 15 reads FIG. 15A-C, Figure 22 reads FIGs. 22A-D, Figure 23 reads FIGs. 23A-B, Figure 24 reads FIGs. 24A-C, and Figure 30 reads FIG.30A-C. The MPEP sets out the standard for drawings at 608.02(V) which provides 37 CFR 1.84(u)(1) that states partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter (see MPEP 608.02(V) section 37 CFR 1.84(u)(1)). Therefore, FIG. 14A-C should read FIG. 14A, FIG. 14B, FIG. 14C, FIG. 15A-C should read FIG. 15A, FIG. 15B, FIG. 15C, FIGs. 22A-D should read FIG. 22A, FIG. 22B, FIG. 22C, FIG. 22D, FIGs. 23A-B should read FIG. 23A, FIG. 23B, FIGs. 24A-C should read FIG. 24A, FIG. 24B, FIG. 24C, and FIG.30A-C should read FIG. 30A, FIG. 30B, FIG. 30C.Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant states that Figs. 15B, 16, and 23C are newly submitted as black and white drawings, rather than color (Reply p. 1). However, the drawing files received on 09/26/2025 still contain colored figures (Figure 15B contains blue boxes in the graph, Figure 16 contains blue lines in the graph, and Figure 23C contains molecules with colored atoms and bonds specifically the molecules Perlolyrine, Jatrorrhizine, Lysicamine, and Columbamine).
Applicant states that Fig. 28 has been amended to enlarge the “output” text (Reply p. 1). However, figure 28 in the drawing files received on 09/26/2025 still contains illegible text (more specifically all the text that is within the box of Figure 28).
Claim Warning
Applicant is advised that should claim 67 be found allowable, claim 121 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See 608.01(m).
Claim Interpretation
Claims 1, 34, 40, 67, 97, and 121 recite “transcultural dictionaries”. The instant disclosure provides “transcultural dictionaries” refers to a search dictionary that collates Western and non-Western epistemological understanding of terms (instant disclosure [0214]).
Claim Rejections - 35 USC § 112
The rejection on the ground of 112/b of claims 1, 2, 4-8, 10, 11, 17, 23, 33, 34, 40, 59, 67, 69, 97, and 121 for reciting “wherein the analysis uses transcultural dictionaries to allow searches within distinct TMS data sets embodying different epistemologies and terminologies” in Office action mailed 26 March 2025 is withdrawn in view of the amendment which removes “to allow searches” received 26 September 2025.
The rejection on the ground of 112/b of claim 6 for reciting a limitation that lacked antecedent basis in Office action mailed 26 March 2025 is withdrawn in view of the amendment which has claim 6 depend from claim 2 which provides proper antecedent basis for the limitation received 26 September 2025.
The rejection on the ground of 112/b of claim 10 for reciting a limitation that lacked antecedent basis in Office action mailed 26 March 2025 is withdrawn in view of the amendment which has claim 10 depend from claim 2 which provides proper antecedent basis for the limitation received 26 September 2025.
The rejection on the ground of 112/b of claim 33 for reciting “a minimal number of essential compounds to achieve a therapeutic outcome” in Office action mailed 26 March 2025 is withdrawn in view of the amendment which cancels claim 33 received 26 September 2025.
The rejection on the ground of 112/b of claim 34 for reciting “wherein said further analysis comprises, after outputting one or more selected from” in Office action mailed 26 March 2025 is withdrawn in view of the amendment “wherein said further analysis comprises” received 26 September 2025.
The rejection on the ground of 112/b of claim 59 for reciting “current source (plant or animal)” in Office action mailed 26 March 2025 is withdrawn in view of the amendment which removes this language received 26 September 2025.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 23, 34, 67, and 121 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The rejections below are newly cited necessitated by amendment.
Claim 6 recites “wherein the processed and normalized formalized pharmacopeias…” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear which “processed and normalized formalized pharmacopeias from one or more geographic regions associated with TMS” that “the processed and normalized formalized pharmacopeias…” is referring to. For the sake of furthering examination this limitation will be interpreted as “wherein each processed and normalized formalized pharmacopeias…”.
Claim 23 recites “The method of claim 11” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because claim 11 has been canceled. For the sake of furthering examination this claim will be interpreted as referring to and depending from independent claim 1.
Claim 34 recites “The method of claim, wherein said further analysis comprises…” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear which claim “The method of claim” is referring to. Further, claim 1 just recites analyzing and refers to “the analysis”, but it is not clear what analysis “said further analysis” in claim 34 is referring to. For the sake of furthering examination this claim will be interpreted as “The method of claim 1, wherein the analysis comprises” which makes clear that claim 34 is referring to independent claim 1 and that claim 34 is meant to further limit the active step of “analyzing, in a single computational space, data from a plurality of traditional medicine systems”.
Claim 67 and 121 recite “wherein populating the transcultural dictionaries with additional data developed by the machine learning algorithm comprises generating a therapeutic dictionary” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear if this limitation is adding an additional active step of populating the transcultural dictions further limiting the method of claim 1. The MPEP states at 2111.04(I) that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps” however populating the transcultural dictionaries with additional data developed by the machine learning algorithm is not previously recited as a manipulative step in the method. Further, claims 67 and 121 recite “the machine learning algorithm”. There is insufficient antecedent basis for this limitation in the claim. The indefiniteness arises because the claim does not make clear what “the machine learning algorithm” is. This rejection could be overcome by amendment of the limitation to “a machine learning algorithm”. It is noted that this issue has arisen from having claim 67 and claim 121 depend from claim 1 rather than claim 34 which provides “populating the transcultural dictionaries” as a manipulative step. For the sake of furthering examination these limitations will be interpreted as generating a therapeutic indication dictionary.
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.
The rejection below has been modified necessitated by amendment.
Claims 1, 2, 4-8, 10, 23, 34, 40, 59, 67, 69, 97, 121, 132, 153, and 154 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 1, 2, 4-8, 10, 23, 34, 40, 59, 67, 69, 97, 121, 153 and 154 fall under the statutory category of a process and claim 132 falls under the statutory category of a machine.
(Step 2A Prong 1)
Under the BRI, the instant claims recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mental process”, such as procedures for evaluating, analyzing or organizing information, and forming judgement or an opinion. The instant claims further recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mathematical concept”, such as mathematical relationships and mathematical equations.
Independent claim 1 recites a mental process of analyzing data from a plurality of traditional medicine systems (TMS), wherein the analysis uses transcultural dictionaries within distinct TMS data sets embodying different epistemologies and terminologies, processing the data associated with the user query to create processed data, wherein processing the data associated with the user query comprises performing a convergence analysis comprising identifying commonalities between two or more of: a disease, a therapeutic indication, one or more compounds derived from one or more organisms, therapeutic approaches from biogeographically and culturally separated locales, coincidence or convergence of one or mor compounds across a plurality of TMS, or coincidence of one or more organisms across a plurality of TMS, wherein the analysis uses data returned by a query to identify reduced number of compounds for a polypharmaceutical composition to achieve a therapeutic outcome.
Independent claim 132 recites a mental process of analyze data from a plurality of the traditional medicine data sets to produce an output.
Claim 23 recites a mental process of performing a divergence analysis comprising identifying alternative compounds derived from one or more organisms, and therapeutic approaches from biogeographically and culturally separated locales across the plurality of TMS. Claim 34 recites mental processes of developing training data sets, populating the transcultural dictionaries, and creating, updating, annotating, analyzing, or manipulating the data. Claims 67 and 121 recite a mental process of generating a therapeutic indication dictionary.
The claims require a process of analyzing data by using transcultural dictionaries, identifying commonalities, and identify reduced number of compounds for a polypharmaceutical composition to achieve a therapeutic outcome. The human mind is capable of analyzing and evaluating data. Dependent claims 2, 4-8, 10, 40, 59, and 69 and 97 further limit the mental process/mathematical concept recited in the independent claim but do not change their nature as a mental process/mathematical concept. Thus, claims 1, 2, 4-8, 10, 23, 34, 40, 59, 67, 69, 97, 121, 132, 153, and 154 recite abstract ideas.
(Step 2A Prong 2)
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). Integration into a practical application is evaluated by identifying whether there are any additional elements recited in the claim and evaluating those additional elements to determine whether they integrate the exception into a practical application.
The additional element in claims 1, 23, and 132 of using a generic computer (and a computer-readable storage medium storing executable instructions when executed by a hardware processor) to perform judicial exceptions does not integrate the judicial exceptions into a practical application because this is applying the judicial exceptions to a generic computer without an improvement to computer technology. This additional element only interacts with the judicial exceptions by being utilized as a tool to perform the judicial exceptions.
The additional element in claim 1, 34, 132, 153, and 154 of receiving data and outputting data (receiving user input, downloading data, a server to communicate with user clients, a database in a memory to store data, a core processor that sends and receives data, a graphical user interface) does not the judicial exceptions into a practical application because this is insignificant extra solution activity of data gathering and outputting data. These additional elements only interact with the judicial exceptions by receiving data to be processed by the judicial exceptions and outputting the processed data.
Thus, the additional elements do not integrate the judicial exceptions into a practical application and claims 1, 2, 4-8, 10, 23, 34, 40, 59, 67, 69, 97, 121, 132, 153, and 154 are directed to the abstract idea.
(Step 2B)
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
The additional element in claims 1, 23, and 132 of using a generic computer (and a computer-readable storage medium storing executable instructions when executed by a hardware processor) to perform judicial exceptions is conventional see MPEP 2106.05(b) and MPEP 2106.05(d)(II).
The additional element in claim 1, 132, 153, and 154 of receiving data and outputting data (receiving user input, downloading data, a server to communicate with user clients, a database in a memory to store data, and a core processor that sends and receives data) is conventional see MPEP 2106.05(b) and MPEP 2106.05(d)(II).
Thus, the additional elements are not sufficient to amount to significantly more than the judicial exception because they are conventional.
Response to Arguments
Applicant's arguments filed 26 September 2025 have been fully considered but they are not persuasive.
Applicant argues that the instant claims can not be practically performed in the human mind. Applicant points to guidance that states “a claim does not recite a mental process when it contains limitations that cannot practically be performed in the human mind” (Reply p. 5).
This argument has been fully considered but found to be not persuasive. The BRI of the claims recite steps of analyzing data from a plurality of traditional medicine systems, processing data by identifying commonalities, analyzing data to identify reduced number of compounds for a polypharmaceutical composition to achieve a therapeutic outcome which encompass observations, evaluations, and judgments on abstract data. The human mind is capable of performing these analyses on abstract data.
Applicant argues that the instant claims recite elements and limitations that reflect an improvement to the functioning to a computer or to another technology. Applicant argues the claims teach an improvement to the field of polypharmaceutical compositions over the art (Reply p. 5).
This argument has been fully considered but found to be not persuasive. The MPEP states at 2106.05(a) “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements… In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception”. The determination of an improvement to technology has two steps, the identification of additional elements (which define the technology) and the evaluation of the additional elements to determine if the improvement is realized in the additional elements either by the additional elements themselves or the additional element in combination with the judicial exception (i.e. the interaction between the judicial exceptions and the additional elements). The claims recite judicial exceptions of analyzing abstract data to identifying reduced number of compounds for a polypharmaceutical composition to achieve a therapeutic outcome. The improvement to the field of polypharmaceutical compositions is not provided by the additional elements of the claim or through the interaction between the judicial exceptions and the additional elements of the claim. Therefore, the improvement of polypharmaceutical compositions is provided by the abstract data analysis which falls under the judicial exception (which can not provide the improvement).
Applicant argues that the claims amount to significantly more than the judicial exceptions because the claims are not practically performed in the human mind and are integrated into a practical application (Reply p. 6).
This argument has been fully considered but found to be not persuasive. As stated above, the BRI of the claims recite steps which encompass observations, evaluations, and judgments on abstract data (the human mind is capable of performing these analyses on abstract data) and the improvement of polypharmaceutical compositions is provided by the abstract data analysis which falls under the judicial exception (which can not provide the improvement). Further, the additional elements of the claims are conventional as discussed under step 2B of the analysis.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The rejection below is newly cited necessitated by amendment.
Claims 1, 2, 4-8, 10, 23, 34, 59, 67, 121, 153 and 154 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Computational and Structural Biotechnology Journal 16 (2018): 600-610; newly cited).
Claim 1 is directed to analyzing, in a single computational space, data from a plurality of traditional medicine systems (TMS), wherein the analysis uses transcultural dictionaries within distinct TMS data sets embodying different epistemologies and terminologies, wherein transcultural dictionaries are dictionaries comprising at least one of: Western and non-Western epistemological understanding of therapeutic indication dictionaries related to traditional medical systems that reflect modern and historical terminology, modern and historical culture-specific terminology, organism dictionaries, compound lists, compound lists associated with a plant source, or therapeutic indication within a geographic location,
Li et al. shows analyzing, in a single computational space (i.e., the YaTCM database), data from a plurality of traditional medicine systems such as TCMID, Database@Taiwan, and TCMSP which are integrated into YaTCM database (Li et al. page 601 section 2.1 Data Sources). The BRI of transcultural dictionaries only requires one of the listed dictionaries. Li et al. shows transcultural dictionaries within datasets where these dictionaries provide prescription-herb relationships and herb-ingredients relationships which are compound lists, compound lists associated with a plant source, and prescriptions which include therapeutic indications for modern applications and traditional applications (Li et al. pages 601-602 section 2.3 Herb-ingredients Relationship).
wherein analyzing comprises: first, receiving a user query; second, using the user query to search the data from the plurality of TMS for data associated with the user query;
Li et al. shows users can retrieve category specific information by entering their preferred query (Li page 604 left col.).
and third, processing the data associated with the user query to create processed data, wherein processing the data associated with the user query comprises performing an in silico convergence analysis comprising identifying commonalities between two or more of: a disease, a therapeutic indication, one or more compounds derived from one or more organisms, therapeutic approaches from biogeographically and culturally separated locales, coincidence or convergence of one or more compounds across a plurality of TMS, or coincidence of one or more organisms across a plurality of TMS;
Li et al. shows a user may query a molecular structure and parameters which will provide a list of candidate molecules for inspection (data associated with the user query) (Li et al. page 604 left col.). Li et al. shows the system provides processing data associated with the user query (such as a molecule in the list of molecules) to provide base information and related information of the molecule in the list of molecules where the related information includes related molecules, diseases, and prescriptions which include therapeutic indications for modern applications and traditional applications (Li et al. page 604 left col. and page 606 figure 5).
and wherein the analysis uses data returned by a query to identify reduced number of compounds for a polypharmaceutical composition to achieve a therapeutic outcome.
Li et al. shows for the information returned by the query, a user can filter superabundant no-drug molecular nodes and links through setting four vital ADMET parameters and Tao's drug-likeness parameter which reducing the number of compounds in a composition that is linked to a therapeutic outcome (Li page 604 right col.).
Claim 2 is directed to wherein the data from the plurality of TMS comprise at least one of: medical formulations. Claims 4-8 and 10 further limit data not associated with medical formulations.
The BRI of the claim only requires that the data from the plurality of TMS includes one of the following data listed in the claim (such as medical formulations). Li et al. shows the data from the plurality of TMS include medical formulations (i.e., prescriptions) (Li et al. pages 603-604 section 3.3.2 prescription exploration). It is noted that claims 4-8 and 10 further limit other data that is not required by the claim.
Claim 23 is directed wherein processing the searched data comprises performing an in-silico divergence analysis comprising identifying alternative compounds derived from one or more organisms, and therapeutic approaches from biogeographically and culturally separated locales across the plurality of TMS.
Li et al. shows identifying alternative compounds derived from organisms through related compounds, related herbs, and prescriptions (Li et al. page 604 left- right col. and 606 figure 5). Li et al. shows identifying prescriptions containing compounds with therapeutic indications in modern applications and traditional applications where prescription data is derived from databases including different biogeographical locations (Li et al. page 604 left and right col. and page 606 figure 5D-2).
Claim 34 is directed to wherein said analysis further comprises, developing training data sets for one or more machine learning models, populating the transcultural dictionaries with additional data developed by a machine learning algorithm, and creating, updating, annotating, processing, downloading, analyzing, or manipulating the data from the plurality of TMS.
Li et al. shows databases, books, and scientific literature to be mined utilizing a text mining tool, populating a curated database with data produced by the text mining tool, and updating the database with the text mining tool (Li et al. page 601 right col.). It is noted that the steps of creating, updating, annotating, processing, downloading, analyzing, or manipulating the data is recited in the alternative form and only require one operation to be performed.
Claim 59 is directed to wherein the user query input comprises one or more phytomedical compounds or formulations.
Li et al. shows the user query input can be a prescription which is a formulation (Li et al. page 604 left col.).
Claims 67 and 121 are directed to generating a therapeutic indication dictionary.
Li et al. shows generating a therapeutic indication dictionary as the ingredients-targets-disease relationships (Li et al. page 602 left col.).
Claim 153 is directed to wherein the method further comprises receiving the user query by way of a graphical user interface (GUI).
Li et al. shows YaTCM can be accessed through web browsers and provides a graphical user interface for receiving the user query (Li et al. page 604 left col. and page 606 figure 5A).
Claim 154 is directed to wherein the method further comprises displaying the reduced number of compounds to achieve a therapeutic outcome by way of a graphical user interface.
Li et al. shows displaying the reduced number of compounds to achieve a therapeutic outcome by displaying filtered results as a portable network graphic format (Li et al. page 606 figure 5D-8).
Claim Rejections - 35 USC § 103
The rejection on the ground of 103 of claims 1, 2, 4-8, 10, 11, 17, 23, 33, 34, 59, 67, and 121 as being unpatentable over Guo et al. (Pharmacol Res. Epub 2020 Jul 17; previously cited) in view of Bultum et al. (BMC Complement Altern Med 19, 212 (2019); previously cited) in Office action mailed 26 March 2025 is withdrawn in view of the amendment of identifying commonalities between two or more of: a disease, a therapeutic indication, one or more compounds derived from one or more organisms, therapeutic approaches from biogeographically and culturally separated locales, coincidence or convergence of one or more compounds across a plurality of TMS, or coincidence of one or more organisms across a plurality of TMS; and wherein the analysis uses data returned by a query to identify reduced number of compounds for a polypharmaceutical composition to achieve a therapeutic outcome received 26 September 2025.
The rejection on the ground of 103 of claims 40 and 69 as being unpatentable over Guo et al. in view of Bultum et al. and further in view of Herrera-Hernandez et al. (Proceedings of the Institution of Mechanical Engineers, Part H. 2016;230(12):1061-1073; previously cited) in Office action mailed 26 March 2025 is withdrawn in view of the amendment of identifying commonalities between two or more of: a disease, a therapeutic indication, one or more compounds derived from one or more organisms, therapeutic approaches from biogeographically and culturally separated locales, coincidence or convergence of one or more compounds across a plurality of TMS, or coincidence of one or more organisms across a plurality of TMS; and wherein the analysis uses data returned by a query to identify reduced number of compounds for a polypharmaceutical composition to achieve a therapeutic outcome received 26 September 2025.
The rejection on the ground of 103 of claim 97 as being unpatentable over Guo et al. in view of Bultum et al. and further in view of Showman et al. (Fitoterapia 100, November 22, 2014, pp. 56-67; cited in IDS received 09 March 2023) in Office action mailed 26 March 2025 is withdrawn in view of the amendment of identifying commonalities between two or more of: a disease, a therapeutic indication, one or more compounds derived from one or more organisms, therapeutic approaches from biogeographically and culturally separated locales, coincidence or convergence of one or more compounds across a plurality of TMS, or coincidence of one or more organisms across a plurality of TMS; and wherein the analysis uses data returned by a query to identify reduced number of compounds for a polypharmaceutical composition to achieve a therapeutic outcome received 26 September 2025.
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 (i.e., changing from AIA to pre-AIA ) 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, 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 rejection below is newly recited necessitated by amendment.
Claims 40 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Computational and Structural Biotechnology Journal 16 (2018): 600-610; newly cited) as applied to claim 1 above, and further in view of Herrera-Hernandez et al. (Proceedings of the Institution of Mechanical Engineers, Part H. 2016;230(12):1061-1073; previously cited).
Claim 40 is directed to wherein at least one transcultural dictionary of the transcultural dictionaries comprises a search dictionary that collates Western and non-Western epistemological understanding of migraine and migraine-like patient presentations.
Claim 69 is directed to wherein the first user input query comprises a user selected clinical indication, wherein the user selected clinical indication is pain.
Li et al. as applied to claim 1 does not explicitly show wherein the user selected clinical indication is pain.
When combined with Li et al., Herrera-Hernandez et al. shows a system that can be traversed using symptoms from western medicine or traditional medicine to identify treatments in traditional medicine or western medicine. Herrera-Hernandez et al. shows inputting painful urination into the system which is part of a symptom pattern which can be mapped to western medicine symptoms for identification of a disease understanding in western medicine (Herrera-Hernandez et al. page 1070 left col.). Further, Herrera-Hernandez et al. shows information about relationships of a symptom of headache behind the eyes (migraine-like patient presentation) (Herrera-Hernandez et al. page 1071 left col.).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to combine reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date to have combined the analysis of traditional medicine compositions to identify compounds with a pharmacological effect of Li et al. with the ability to search symptoms that can be mapped between cultural understandings to identify treatments because this would allow one to use western medicine symptom patterns that can be mapped to non-western understanding of the symptoms and treatments to identify herbs of interest to further analyze (Herrera-Hernandez et al. page 1065 figure 2 and 1068 figure 5). One would have a reasonable expectation of success because Herrera-Hernandez et al. can intake symptoms which can identify traditional medicine treatments (prescriptions with herbs) which can be used as input to retrieve compounds for these treatments.
The rejection below is newly recited necessitated by amendment.
Claim 97 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Computational and Structural Biotechnology Journal 16 (2018): 600-610; newly cited) as applied to claim 1 above, and further in view of Showman et al. (Fitoterapia 100, November 22, 2014, pp. 56-67; previously cited).
Claim 97 is directed to wherein at least one transcultural dictionary of the transcultural dictionaries comprises a search dictionary that collates Western and non-Western epistemological understanding of piper species associated with a therapeutic indication.
Li et al. as applied to claims 1 does not explicitly show Western and non-Western epistemological understanding of piper species associated with a therapeutic indication.
Like Li et al., Showman et al. shows information on western and non-western understandings of herbs for medicinal purposes. Showman et al. shows information on piper species for medicinal purposes and potential toxicology concerns (Showman et al. page 56 abstract).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to modify reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date to have combined the analysis method employing a traditional medicine database of Li et al. with the information on piper species as shown by Showman et al. because this would allow a comprehensive method that can identify pharmacological effective compounds in piper species (Showman et al. page 56 abstract). One would have a reasonable expectation of success because Showman et al. shows information of piper species which may utilized by the analysis of Li et al.
The rejection below was previously recited.
Claim 132 is rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (Pharmacol Res. Epub 2020 Jul 17; previously cited) in view of Bultum et al. (BMC Complement Altern Med 19, 212 (2019); previously cited).
Independent claim 132 is directed to A phytomedicine analytics for research optimization at scale (PhAROS) system for analyzing a plurality of traditional medical systems in a single computational space, the PhAROS system comprising: a computer server configured to communicate with one or more user clients (PhAROSUSER), comprising: (a) a database (PhAROS_BASE) comprising a memory configured to store a collection of data, the collection of data comprising: raw and optionally pre-processed data from a plurality of traditional medicine data sets; and optionally one or more of: plant data sets; literature-based text documents (corpus); and machine learning data sets;
Guo et al. shows analyzing chemical compounds of XiaoErFuPi (XEFP) (traditional medicine) in a single computational space by retrieving the chemical compounds from the TCM databases TCMSP and TCMID which is interpreted as a communication to databases which hold collected data in a computer environment (Guo et al. page 2 right col. and page 4 right col.).
(b) a computer core processor (PhAROS_CORE), wherein the PhAROS_CORE is configured to receive and process the collection of data from the PhAROS_BASE to generate processed data;
Guo et al. shows processing collected data to obtain in-silico predicted toxicological and side-effect data of medical compound datasets using admetSAR software which shows the use of a computer environment (Guo et al. page 4 right col.).
(d) a computer-readable storage medium storing executable instructions that, when executed by a hardware processor, cause the PhAROS_ CORE to communicate with the PhAROS_BASE and one or more of the searchable repositories to analyze data from a plurality of the traditional medicine data sets to produce an output responsive to a user query input into the PhAROS system.
Guo et al. shows performing unsupervised machine learning based on cellular function fingerprints using data of the retrieved chemical compounds of XEFP and FDA-approved drugs which is interpreted as being an analysis in a computer environment (Guo et al. page 4 right col. and page 5 left col.).
Guo et al. does not show (c) one or more searchable repositories having data and optionally pre-processed data, wherein each searchable repository comprises a memory configured to store data entries, wherein the PhAROS_CORE is configured to send the processed data to and receive data from each of the searchable repositories, wherein each of the searchable repositories is configured to receive processed data from the PhAROS_ CORE and send data and optionally pre-processed data to the PhAROS_ CORE;
When combined with Guo et al., Bultum et al. shows searchable repositories which hold data about traditional medicine that are configured to store processed data from the analysis (Bultrum et al. page 3 left col. and page 6 figure 2).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to combine reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date to have combined the unsupervised analysis of compounds from traditional medicine prescriptions to identify new compounds with pharmacological effects on diseases in datasets of Guo et al. with the use of an additional Ethiopian database which contains herb prescriptions (with compounds) that has entities that have standardized IDs linked with cultural names to facilitate retrieval of data pertinent to an analysis of Bultum et al. because this will allow the analysis of traditional medicines from different databases to identify compounds that act on a disease as shown by Bultum et al. (page 3 left and right column). One would have a reasonable expectation of success because Bultum et al. contains information on traditional medicines linked to phenotypes (with international identifiers) which can be traversed to retrieve compound information which can be used as input into the unsupervised analysis of Guo et al. for the discovery of compositions with similar pharmacological effects.
Response to Arguments
Applicant's arguments filed 26 September 2025 have been fully considered but they are not persuasive.
Applicant argues that Guo in view of Bultum together do not render the instant claims obvious and provides arguments that are directed to the limitations of claim 1 which performs an analysis to identify a reduced amount of compounds to achieve a therapeutic outcome (Reply p. 3-4).
These arguments have been fully considered but found to be not persuasive. The arguments that are directed to the limitations of claim 1 are not persuasive because Guo et al. and Bultum et al. are not relied upon for the newly recited rejection of claim 1.
Applicant argues that Guo in view of Bultum together do not render the instant claims obvious (Reply p. 3-4). Applicant requests that the same reconsideration and withdrawal of rejection be applied to each of the instant dependent claims and claim 132 (Reply p. 5).
These arguments have been fully considered but found to be not persuasive. Applicant provides arguments that the claimed invention is not obvious over Guo in view of Bultum without specifically pointing out how the language of claim 132 is patentably distinct from Guo in view of Bultum. Applicant provides arguments that rely on limitations only present in claim 1 and does not provide arguments pertaining to the recited limitations of claim 132. Therefore, it is not clear what is being argued for patentability regarding independent claim 132. The BRI of claim 132 recites a system with a database which contains traditional medicine data to be analyzed by a processor with searchable repositories. Guo et al. in view of Bultum et al. provide a system that has a database with searchable repositories of traditional medicine data and a system that allows for analyzing this data. Therefore, Guo et al. in view of Bultum et al. renders claim 132 obvious.
Conclusion
No claims are allowed.
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 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.
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/J.E.H./Examiner, Art Unit 1685
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685