DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to the claims filed on 22 June 2026. Claims 1 and 4-6 were amended. Claims 1-10 are currently pending and have been examined.
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 are rejected under 35 USC § 101
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Claims 1-10 fall within one or more statutory categories. Claims 1-5 fall within the category of a process. Claims 6-10 fall within the category of a machine.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1-10 recite an abstract idea. Representative claim 1 recites:
accessing a genetic test result for the user and a proposed drug for administration to the user, wherein the proposed drug is in a drug category;
determining whether the proposed drug is present in an internal database, wherein the internal database comprises a list of genes that are associated with a plurality of drugs based on clinical relevance of the gene to the actions of the plurality of drugs;
in response to determining that the proposed drug is not present in the internal database:
searching an external database for a major metabolite and an enzyme responsible for forming the major metabolite, wherein the major metabolite and the enzyme are associated with the proposed drug, and
determining whether there is a mutation in a user gene associated with the enzyme that pharmacokinetically impacts the proposed drug based on the genetic test result;
in response to determining that the proposed drug is present in the internal database:
determining a clinically relevant enzyme associated with the proposed drug from the internal database, and
determining whether there is a mutation in the clinically relevant gene based on the genetic test result;
determining whether there is a problematic gene-drug interaction associated with the proposed drug by:
determining a metabolic component value for the proposed drug based on the received genetic test result, wherein the metabolic component value is calculated as a weighted summation of phenotypic color designations for clinically relevant metabolic genes associated with the proposed drug, each phenotypic color designation being multiplied by a relative importance value representing the contribution of the respective gene to the metabolism of the proposed drug,
determining a response component value for the proposed drug based on the received genetic test result, wherein the response component value is assigned as the highest phenotypic color designation value among clinically relevant response genes associated with the proposed drug,
assigning a drug category from a plurality of categories for the proposed drug based on the greater of the metabolic component value and the response component value, wherein the drug category indicates a severity of any drug-gene interactions for the user and the proposed drug, and
determining whether there is at least a threshold pharmacokinetic impact on the proposed drug caused by the mutation based on the severity of any drug-gene interactions for the user;
in response to determining that there is the problematic gene-drug interaction, identifying an alternative drug from the drug category; and
providing a report to the user, the report comprising the problematic gene-drug interaction and the alternative drug, wherein the report … presents the drug category as a color-coded indicium corresponding to the severity of the drug-gene interaction for the user.
Therefore, the claim as a whole is directed to “checking for gene-drug interactions”, which is an abstract idea because it is a method of organizing human activity. “Checking for gene-drug interactions” is considered to be a method of organizing human activity because it is an example of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The broadest reasonable interpretation of the present claims include the interaction between a caregiver and a patient.
Alternatively, the claims are considered to be directed to a mental process because they include concepts capable of being performed in the human mind (including an observation, evaluation, judgment, opinion).
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the following additional element(s):
internal and external databases;
a graphical user interface.
The additional elements individually or in combination do not integrate the exception into a practical application. These additional elements merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claim 1 is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 1 does not include additional elements, considered individually or in combination, that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element(s), individually and in combination, merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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))Accordingly, claim 1 is ineligible.
Dependent claim 2 recites the method of claim 1, comprising:
providing, to a healthcare provider associated with the user, the report.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 2 is considered to be ineligible.
Dependent claim 3 recites the method of claim 1, comprising:
determining whether the user has a problematic gene-drug interaction with the alternative drug.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 3 is considered to be ineligible.
Dependent claim 4 recites the method of claim 1, wherein:
the threshold pharmacokinetic impact comprises over-metabolizing functionality of the enzyme with respect to the proposed drug.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 4 is considered to be ineligible.
Dependent claim 5 recites the method of claim 1, wherein:
the threshold pharmacokinetic impact comprises under-metabolizing functionality of the enzyme with respect to the proposed drug.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 5 is considered to be ineligible.
Claims 6-10 are parallel in nature to claims 1-5. Accordingly claims 6-10 are rejected as being directed towards ineligible subject matter based upon the same analysis above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gostyla et al. (U.S. 2020/0135314), hereinafter “Gostyla,” in view of Pratsevall Garcia et al. (U.S. 2016/0314251), hereinafter “Pratsevall,” and further in view of Massey et al. (U.S. 2016/0012181), hereinafter “Massey.”
Regarding Claim 1, Gostyla discloses a :
accessing a genetic test result for the user (See Gostyla [0027] a user provides their genetic information by means of a pharmacognetic (PGX) test. See also [0073].) and a proposed drug for administration to the user, wherein the proposed drug is in a drug category (See Gostyla [0024] potential adverse interactions between prescription and over-the-counter pharmaceuticals that the patient is using while considering other patient characteristics such as the patient's genetic makeup. [0025] enter a medication name, an NDC number, and/or scan a medication barcode for a specific desired pharmaceutical that the user has been prescribed or is interested in purchasing. The system checks the user's profile to determine if the pharmaceutical may cause an adverse reaction or genetic threat to the user. [0034] application also asks the patient to identify any medications the patient may be using. See also [0039] and [0057].);
determining whether the proposed drug is present in an internal database, wherein the internal database comprises a list of genes that are associated with a plurality of drugs based on clinical relevance of the gene to the actions of the plurality of drugs (See Gostyla [0036] proprietary databases can be created for specific use-cases. These meet the broadest reasonable interpretation of “internal databases.” [0035] system includes information about medications, drugs, vitamins, and supplements, their ability to interact with other drugs, foods, allergies, etc.) ;
in response to determining that the proposed drug is not present in the internal database: searching an external database for a major metabolite and an enzyme responsible for forming the major metabolite, wherein the major metabolite and the enzyme are associated with the proposed drug (See Gostyla [0035] third-party databases can be accessed to determine if any interactions exist for a particular patient. [0073] he profile may include translation table for specific genes and associated SNPs with haplotype/genotype/phenotype. [0074] information is used to determine patient metabolizer status. [0072] this genetic information is used to determine if there any interactions between the user's genetic makeup and any medications the user is currently taking or wishes to take.), and
determining whether there is a mutation in a user gene associated with the enzyme that pharmacokinetically impacts the proposed drug based on the genetic test result (See Gostyla [0074] system can determine if a user has an SNP (i.e. mutation) that makes them an extensive metabolizer. See also [0040].);
in response to determining that the proposed drug is present in the internal database: determining a clinically relevant enzyme associated with the proposed drug from the internal database (See Gostyla [0035] third-party databases can be accessed to determine if any interactions exist for a particular patient. [0073] he profile may include translation table for specific genes and associated SNPs with haplotype/genotype/phenotype. [0074] information is used to determine patient metabolizer status. [0072] this genetic information is used to determine if there any interactions between the user's genetic makeup and any medications the user is currently taking or wishes to take.), and
determining whether there is a mutation in the clinically relevant gene based on the genetic test result (See Gostyla [0074] system can determine if a user has an SNP (i.e. mutation) that makes them an extensive metabolizer.);
determining whether there is a problematic gene-drug interaction associated with the proposed drug (See Gostyla [0037] conflicts could be conflicts between two or more drugs, a drug and a patient's illness, a drug and an allergy, a drug and food and/or beverage being taken by the patient, between a drug and some aspect of the patient's lifestyle, and a drug and the genetic makeup of the patient.), and
determining whether there is at least a threshold pharmacokinetic impact on the proposed drug caused by the mutation based on the severity of any drug-gene interactions for the user (See Gostyla [0047] notifications can include a warning of a conflict, an indication as to the severity of a conflict (i.e., mild, moderate, severe) or an indication that there is no conflict. Thus, the patient receives a high level of confidence when it comes to determining if there are any potential medical hazards that the patient needs to be concerned with when the patient purchases a drug. See also [0074].);
in response to determining that there is the problematic gene-drug interaction, identifying an alternative drug from the drug category (See Gostyla [0026] provides alternate pharmaceutical recommendations to the user tailored to the user's specific healthcare and genetic profile.); and
providing a report to the user, the report comprising the problematic gene-drug interaction (See Gostyla [0025] If a conflict does exist, the system generates a real-time alert to the user warning them of the conflict and/or provide a description of the adverse reactions.) and the alternative drug (See Gostyla [0026] provides alternate pharmaceutical recommendations to the user tailored to the user's specific healthcare and genetic profile.).
Gostyla does not disclose:
determining whether there is a problematic gene-drug interaction associated with the proposed drug by: determining a metabolic component value for the proposed drug based on the received genetic test result, wherein the metabolic component value is calculated as a weighted summation of phenotypic color designations for clinically relevant metabolic genes associated with the proposed drug, each phenotypic color designation being multiplied by a relative importance value representing the contribution of the respective gene to the metabolism of the proposed drug,
determining a response component value for the proposed drug based on the received genetic test result,
wherein the response component value is assigned as the highest phenotypic color designation value among clinically relevant response genes associated with the proposed drug,
assigning a drug category from a plurality of categories for the proposed drug based on the greater of the metabolic component value and the response component value, wherein the drug category indicates a severity of any drug-gene interactions for the user and the proposed drug.
Pratsevall teaches:
determining whether there is a problematic gene-drug interaction associated with the proposed drug by: determining a metabolic component value for the proposed drug based on the received genetic test result (See Pratsevall [0022] system can acquire genetic information about a patient, including single nucleotide polymorphisms (SNPs), wherein said genetic information includes information regarding genes and genetic variants associated to metabolism. Fig. 2 and [0149-0153] these values will be used later in this table depicting response and metabolic information.),
determining a response component value for the proposed drug based on the received genetic test result (See Pratsevall [0022] acquiring genetic information about a patient, including single nucleotide polymorphisms (SNPs), wherein said genetic information includes information regarding genes and genetic variants which are not associated to metabolism (such as genes and genetic variants associated to drug response and adverse drug reactions). Therefore, there is information connected to metabolism as well as separate inform connected to drug response. Fig. 2 and [0149-0153] these values will be used later in this table depicting response and metabolic information. See also [0033] and [0037].),
assigning a drug category from a plurality of categories for the proposed drug based on the greater of the metabolic component value and the response component value (See Pratsevall [0014] system analyzes important genomic variants affecting the metabolism and response to behavioral health medications in individual patients. [0033] specific genetic variant affects the drug response, drug metabolism and/or adverse drug reactions.), wherein the drug category indicates a severity of any drug-gene interactions for the user and the proposed drug (See Pratsevall Fig. 2 and [0149-0153] these values are used in this table depicting response and metabolic information with color coding and different symbols that also indicate severity. See also [0033] and [0037].),
wherein the report is displayed via a graphical user interface that presents the drug category as a color-coded indicium corresponding to the severity of the drug-gene interaction for the user (See Pratsevall Fig. 2 and [0149-0153] these values are used in this table depicting response and metabolic information with color coding and different symbols that also indicate severity. See also [0033] and [0037]. [0044] personalized recommendations are displayed according to a color code, the above described visual highlighting including at least the use of a conspicuous or eye-catching or flashing color (such as red) for the personalized recommendation to be highlighted according to the risk criterion.).
The system of Pratsevall is applicable to the disclosure of Gostyla as they both share characteristics and capabilities, namely, they are directed to determining gene-drug interactions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gostyla to include more elaborate detail as taught by Pratsevall. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Gostyla in order to provide more elaborated personalized recommendations about drug use (see Pratsevall [0017]).
Massey teaches:
wherein the metabolic component value is calculated as a weighted summation of phenotypic color designations for clinically relevant metabolic genes associated with the proposed drug (See Massey [0029]-[0030] this shows the calculation of a metabolic component value using a weighted summation of phenotype color designation values.), each phenotypic color designation being multiplied by a relative importance value representing the contribution of the respective gene to the metabolism of the proposed drug (See Massey [0021] The relative clinical importance of each tested gene's phenotype was assigned by subjective determination of clinical relevance and assigned a % relevance value that sums to 100% across all tested relevant genes.),
wherein the response component value is assigned as the highest phenotypic color designation value among clinically relevant response genes associated with the proposed drug (See Massey [0032] the determined RCV value is simply the highest PCD value used in the previous calculation of the MCV.).
The system of Massey is applicable to the disclosure of Gostyla in view of Pratsevall as they both share characteristics and capabilities, namely, they are directed to quantifying gene-drug interactions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gostyla to include the calculation of MCV and RCV as taught by Massey. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Gostyla in view of Pratsevall in order to address the issues of general lack of knowledge of genetics and pharmacogenetics in particular, time constraints related to their daily patient volumes, and the necessity to look at and integrate multiple sections of the report related to the different genes tested and their significance for a particular drug (See Massey [0003]-[0004]).
Regarding claim 2, Gostyla in view of Pratsevall discloses the method of claim 1 as discussed above. Gostyla further discloses a method, comprising:
providing, to a healthcare provider associated with the user, the report (See Gostyla [0048] The report may be forwarded to the patient, physician and/or pharmacist. See also [0029].).
Regarding claim 3, Gostyla in view of Pratsevall discloses the method of claim 1 as discussed above. Gostyla further discloses a method, comprising:
determining whether the user has a problematic gene-drug interaction with the alternative drug (See Gostyla [0037] conflicts could be conflicts between two or more drugs, a drug and a patient's illness, a drug and an allergy, a drug and food and/or beverage being taken by the patient, between a drug and some aspect of the patient's lifestyle, and a drug and the genetic makeup of the patient. This includes a comparison of genetic information to the alternative drug.).
Regarding claim 4, Gostyla in view of Pratsevall discloses the method of claim 1 as discussed above. Gostyla does not further disclose a method, wherein:
the threshold pharmacokinetic impact comprises over-metabolizing functionality of the enzyme with respect to the proposed drug.
Pratsevall teaches:
the threshold pharmacokinetic impact comprises over-metabolizing functionality of the enzyme with respect to the proposed drug (See Pratsevall [0035] gene phenotype can be used to determine if a user is a poor metabolizer. [0038] system can check how the concomitant medication or substance alters the metabolizer capacity of the patient with respect to one or more of said drugs. This is under stood to include over and under metabolizing.).
The system of Pratsevall is applicable to the disclosure of Gostyla as they both share characteristics and capabilities, namely, they are directed to determining gene-drug interactions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gostyla to include more elaborate detail as taught by Pratsevall. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Gostyla in order to provide more elaborated personalized recommendations about drug use (see Pratsevall [0017]).
Regarding claim 5, Gostyla in view of Pratsevall discloses the method of claim 1 as discussed above. Gostyla does not further disclose a method, wherein:
the threshold pharmacokinetic impact comprises under-metabolizing functionality of the enzyme with respect to the proposed drug.
Pratsevall teaches:
the threshold pharmacokinetic impact comprises under-metabolizing functionality of the enzyme with respect to the proposed drug (See Pratsevall [0035] gene phenotype can be used to determine if a user is a poor metabolizer. [0038] system can check how the concomitant medication or substance alters the metabolizer capacity of the patient with respect to one or more of said drugs. This is under stood to include over and under metabolizing.).
The system of Pratsevall is applicable to the disclosure of Gostyla as they both share characteristics and capabilities, namely, they are directed to determining gene-drug interactions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gostyla to include more elaborate detail as taught by Pratsevall. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Gostyla in order to provide more elaborated personalized recommendations about drug use (see Pratsevall [0017]).
Regarding claims 6-10, Gostyla in view of Pratsevall discloses the method of claims 1-5 as discuss above. Claims 6-10 recite a system that performs a method that is substantially similar to the method of claims 1-5. Accordingly, claims 6-10 are rejected based on the same analysis.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 19/117,365 in view of Massey et al. (U.S. 2016/0012181), hereinafter “Massey.” Although the claims at issue are not identical, they are not patentably distinct from each other because they recite the same subject matter, especially when claims 1 and 7 of the 19/117,365 application are compared to independent claim 1 of the present application. However, the 19/117,365 application does not include the following in its claims:
wherein the metabolic component value is calculated as a weighted summation of phenotypic color designations for clinically relevant metabolic genes associated with the proposed drug, each phenotypic color designation being multiplied by a relative importance value representing the contribution of the respective gene to the metabolism of the proposed drug,
wherein the response component value is assigned as the highest phenotypic color designation value among clinically relevant response genes associated with the proposed drug.
Massey teaches:
wherein the metabolic component value is calculated as a weighted summation of phenotypic color designations for clinically relevant metabolic genes associated with the proposed drug (See Massey [0029]-[0030] this shows the calculation of a metabolic component value using a weighted summation of phenotype color designation values.), each phenotypic color designation being multiplied by a relative importance value representing the contribution of the respective gene to the metabolism of the proposed drug (See Massey [0021] The relative clinical importance of each tested gene's phenotype was assigned by subjective determination of clinical relevance and assigned a % relevance value that sums to 100% across all tested relevant genes.),
wherein the response component value is assigned as the highest phenotypic color designation value among clinically relevant response genes associated with the proposed drug (See Massey [0032] the determined RCV value is simply the highest PCD value used in the previous calculation of the MCV.).
The system of Massey is applicable to the claims of the 19/117,365 application as they both share characteristics and capabilities, namely, they are directed to quantifying gene-drug interactions. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the 19/117,365 application to include the calculation of MCV and RCV as taught by Massey. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the 19/117,365 application in view of Pratsevall in order to address the issues of general lack of knowledge of genetics and pharmacogenetics in particular, time constraints related to their daily patient volumes, and the necessity to look at and integrate multiple sections of the report related to the different genes tested and their significance for a particular drug (See Massey [0003]-[0004]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 22 June 2026, with respect to the 35 U.S.C. §101 rejection of the claims, have been fully considered but they are not persuasive. First, Applicant argues that the claims recite an improvement to technology under Step 2A, Prong Two (see Applicant Remarks pages 7-9). This is not persuasive. The claims do not recite a technological solution to a technological problem. At most any improvement to the abstract idea of determining gene-drug interactions are those inherent to the use of a computer for automation of a generic task. This is not enough to improve the functioning of a computer as discussed in MPEP 2106.05(a)(I) (See examples such as iii. mere automation). In contract, the additional elements present in the claims merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)).
Next, Applicant argues that the claims apply the judicial exception to effect a particular treatment or prophylaxis (see Applicant Remarks page 9). This is not persuasive. For the element to qualify as a particular treatment or prophylaxis the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. In contrast, the present claims merely provide a report on potential drug alternatives. This does not meet the criteria to qualify as a particular treatment or prophylaxis.
Finally, Applicant argues that the claims include significantly more than the judicial exception (see Applicant Remarks pages 9-10). This is not persuasive. As already discussed above, the additional elements present in the claims, when considered individually or in combination, merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes 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)). This is not enough to amount to significantly more than the judicial exception. Accordingly, the claims remain rejected as being directed to ineligible subject matter.
Applicant's arguments filed 22 June 2026, with respect to the 35 U.S.C. §103 rejection of the claims, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of the newly cited Massey reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Coleman et al. (U.S. 2009/0094059) teaches a system and method for personalized medication management and alert.
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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/B.L.H./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
Prosecution Insights