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
In the response dated March 16, 2026, Applicant amended claims 13, 16, 30, 33, 35, and 36. Claims 14, 15, 31, and 32 were canceled, and claims 1-12 were previously canceled. Claims 13, 16-30, and 33-36 are pending in the current application.
Response to Arguments
Applicant’s arguments with respect to the rejection under 35 U.S.C. 101 have been fully considered but they are not persuasive. Under Prong One, Applicant asserts that the claims recite highly specialized technical process that automatically matches a user’s genetic information against a metabolism database to “programmatically extract personalized metabolic information cannot be practically performed in the human mind, nor is it a mere mental process of a healthcare professional.” Examiner respectfully disagrees. A claim that requires a computer may still recite a mental process. In Benson, the Supreme Court determined that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary (see MPEP 2106.04(a)(2)(III)(C)). In this case, the identified limitations, under their broadest reasonable interpretation, recite generic computer components. That is, other than reciting a linkage processor, input and user terminal device, metabolic database, and genetic information server, nothing in the claim elements precludes the steps form practically being performed in the mind. For example, the identified limitations encompass a healthcare professional collecting side effect information of a medicine, inputting the information into a computer to be presented to the patient upon receipt of the medicine. Under Prong Two, Applicant asserts that integrates the abstract idea into a practical application because of improvements disclosed in the Applicant’s specification. Examiner respectfully disagrees. If the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology (see MPEP 2106.04(a)). Here, the Paragraphs [0004] and [0005] of Applicant’s Specification disclose (with the heading Technical Problem), “However, in the case of online administration instructions, communication with a user becomes complicated as compared to the case of performing administration instructions in a face-to-face manner, and thus the amount of information exchanged with the user is reduced and the quality of administration instructions may be deteriorated” and “…technique capable of improving the quality of online administration instructions.” Paragraphs [0006]-[0009] (with the heading Solution to Problem) disclose various embodiments of the present invention. However, this is a bare assertion of am improvement without the detail necessary to be apparent to a person of ordinary skill in the art. For instance, the alleged improvement of quality of online administration is without detail of the technological aspects of the improvement. Under Step 2B, Applicant asserts that the medicine metabolism database improves the technological functioning of the online dispensing system. Examiner respectfully disagrees. As stated above, Applicant’s specification set forth a bare assertion of an improvement without the detail necessary. The rejection is maintained.
Applicant’s arguments with respect to the rejection under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of acquiring metabolic information from metabolism database.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are in claims 13-29:
a first information acquirer configured to acquire first information…
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 13, 16-30, and 33-36 are rejected under 35 U.S.C. 101 because the claims are not directed to patent eligible subject matter.
Claims 13, 16-30, and 33-36 do fall within at least one of the four categories of patent eligible subject matter because the claims recite a machine (i.e., system, server, and device) and process (i.e., a method).
Although claims 13, 16-30, and 33-36 fall under at least one of the four statutory categories, it should be determined whether the claim wholly embraces a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception (See MPEP 2106 I and II).
Claims 13, 16-30, and 33-36 are directed to a judicial exception (i.e., a law of nature, natural phenomenon, or abstract idea) without significantly more.
Part I: Step 2A, Prong One: Identify the Abstract Idea
Under step 2A, Prong One of the Alice framework, the claims are analyzed to determine if the claims are directed to a judicial exception. MPEP §2106.04(a). The determination consists of a) identifying the specific limitations in the claim that recite an abstract idea; and b) determining whether the identified limitations fall within at least one of the three subject matter groupings of abstract ideas (i.e., mathematical concepts, mental processes, and certain methods of organizing human activity).
The identified limitations of independent claim 13 recite (in bold and italics):
a first information acquirer configured to acquire first information on side effects of a medicine to be delivered to a user on the basis of medicine information on the medicine written in a prescription of the user and genetic information of the user;
a medicine metabolism database in which metabolic information on medicine metabolism for each medicine is stored;
a linkage processor configured to provide the first information as side effect information on the medicine to a presentation information input terminal device used by a presentation information input person who presents information to the user;
a presentation information input terminal device configured to support execution of information presentation through communication with a user terminal device used by the user and to enable reference to the side effect information in the information presentation, with respect to the information presentation of the medicine performed for the user when the presentation information input person delivers the medicine;
wherein the first information acquirer acquires the metabolic information on the medicine written in the prescription of the user from the medicine metabolism database, and the first information includes the acquired metabolic information.
The identified limitations of independent claim 30 recite:
a genetic information server configured to store genetic information of a user;
a presentation information input terminal device used by a presentation information input person who performs information presentation with respect to a medicine to be delivered to the user; and
a linkage processor configured to perform linkage of various types information with a user terminal device used by the user, wherein the linkage processor acquires medicine information on a medicine written in a prescription of the user from the presentation information input terminal device, provides the medicine information to the genetic information server, and provides first information on side effects of the medicine generated by the genetic information server on the basis of the medicine information to the presentation information input terminal device;
wherein the linkage processor acquires metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored, and the first information includes the acquired metabolic information.
The identified limitations of independent claim 35 recite:
acquiring first information on side effects of a medicine to be delivered to a user on the basis of medicine information on a medicine written in a prescription of the user and genetic information of the user;
acquiring metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored, wherein the first information includes the acquired metabolic information; and
providing the first information as side effect information on the medicine to a presentation information input terminal device used by a presentation information input person who presents information to the user, wherein the presentation information input terminal device supports execution of the information presentation through communication with a user terminal device used by the user and enables reference to the side effect information in the information presentation with respect to the information presentation of the medicine to be performed on the user when the pharmacist delivers the medicine.
The identified limitations of independent claim 36 recite:
acquire medicine information on the medicine written in a prescription of the user from the presentation information input terminal device and provide the medicine information to the genetic information server;
acquire metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored; and
provide information on side effects of the medicine generated by the genetic information server on the basis of the medicine information to the presentation information input terminal device,
wherein the information on side effects includes the acquired metabolic information.
The identified limitations, under their broadest reasonable interpretation, cover performance of the limitations in the mind (including observation, evaluation, judgement or opinion) but for the recitation of generic computer components. That is, other than reciting a linkage processor, input and user terminal device, metabolic database, and genetic information server, nothing in the claim elements precludes the steps form practically being performed in the mind. For example, the identified limitations encompass a healthcare professional collecting side effect information of a medicine, inputting the information into a computer to be presented to the patient upon receipt of the medicine. The claim limitations fall within the Mental Processes groupings of abstract ideas. Thus, the claimed invention recites a judicial exception.
Part I: Step 2A, prong two: additional elements that integrate the judicial exception into a practical application
Under step 2A, Prong Two of the Alice framework, the claims are analyzed to determine whether the claims recite additional elements that integrate the judicial exception into a practical application. In particular, the claims are evaluated to determine if there are additional elements or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claims are more than a drafting effort designed to monopolize the judicial exception.
This judicial exception is not integrated into a practical application. As a whole, the linkage processor, input and user terminal device, metabolic database, and genetic information server in the steps are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Dependent claims 16-29, 33, and 34, when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed to an abstract idea.
Since these claims are directed to an abstract idea, the Office must determine whether the remaining limitations “do significantly more” than describe the abstract idea.
Part II. Determine whether any Element, or Combination, Amounts to“Significantly More” than the Abstract Idea itself
Under Part II, the steps of the claims, when considered individually and as an ordered combination, do not improve another technology or technical field, do not improve the functioning of the computer itself, and are not enough to qualify as "significantly more". For example, the steps require no more than a conventional computer to perform generic computer functions. As stated above, the linkage processor, input and user terminal device, metabolic database, and genetic information server in the steps are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Therefore, based on the two-part Mayo analysis, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself. Claims 13, 16-30, and 33-36, when considered individually and as an ordered combination, are rejected as ineligible subject matter under 35 U.S.C. 101.
Dependent claims 16-29, 33, and 34, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional claims do no recite significantly more than an abstract idea.
Claim Rejections - 35 USC § 103
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 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 13, 16-30, and 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Valentine (US 2020/0276088 A1) in view of Baskys (US 2017/0270246 A1).
Regarding claim 13, Valentine discloses an online dispensing system comprising:
a first information acquirer configured to acquire first information on side effects of a medicine to be delivered to a user on the basis of medicine information on the medicine written in a prescription of the user and genetic information of the user (Paragraph [0079]: The listing for each drug includes by definition each drug's respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions);
a linkage processor configured to provide the first information as side effect information on the medicine to a presentation information input terminal device used by a presentation information input person who presents information to the user (Paragraph [0088]: the Prescription module 80b, which is unique to the drug, encompasses the ability of the Prescriber 60, other authorized healthcare professionals, or the Integrated Support Center 40 to input the prescribing information into the Drug Specific App);
a presentation information input terminal device configured to support execution of information presentation through communication with a user terminal device used by the user and to enable reference to the side effect information in the information presentation, with respect to the information presentation of the medicine performed for the user when the presentation information input person delivers the medicine (Paragraphs [0091]: The Interface Device module 80d encompasses many functions: (i) home for the Drug Specific App 10, (ii) enables the Drug Specific App 10 to utilize the Interface Device features to facilitate the Drug Specific App's interface with the Patient, and [0099]: The Patient Reporting 80j module encompasses, as an example: (i) an ability by the Patient 50 to request certain reports, e.g., the last time the Patient 50 took the medication, prescription information details, drug details (brand and generics names, batch number, expiration date, doses remaining, reorder information, drug interactions, typical side effects).
Valentine discloses the limitations above. Valentine does not explicitly disclose:
a medicine metabolism database in which metabolic information on medicine metabolism for each medicine is stored;
wherein the first information acquirer acquires the metabolic information on the medicine written in the prescription of the user from the medicine metabolism database, and the first information includes the acquired metabolic information.
Baskys teaches:
a medicine metabolism database in which metabolic information on medicine metabolism for each medicine is stored (Paragraph [0030]: Upon receiving genetic data, the computer processor executes a code that causes the data to search a database of drugs and nutraceuticals whose effectiveness, side effect profile, metabolism or any other biological function may be affected by the mutation or mutations);
wherein the first information acquirer acquires the metabolic information on the medicine written in the prescription of the user from the medicine metabolism database, and the first information includes the acquired metabolic information (Paragraph [0035]: These drugs and nutraceuticals may be entered separately by the user and the user can observe the changes in the plurality of the interactions between the prescription drugs or nutraceuticals and genetic data, and as a result become aware of potential adverse interactions or a loss of effectiveness of his or her current medications).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Valentine to disclose a medicine metabolism database in which metabolic information on medicine metabolism for each medicine is stored; wherein the first information acquirer acquires the metabolic information on the medicine written in the prescription of the user from the medicine metabolism database, and the first information includes the acquired metabolic information as taught by Baskys. Valentine discloses a drug specific drug dispensing algorithm, and method to improve medication safety and effectiveness (Valentine Abstract). Using the database of drugs and nutraceuticals to search for drug metabolism of Baskys would provide the most effective prescription for the patient since metabolic rates are known to inversely correlate with the likelihood of drug-induced side effects. (Baskys Paragraph [0027]).
Regarding claim 16, Valentine does not explicitly disclose:
wherein the metabolic information includes information on at least one of a metabolic rate, a medicine dosage, and necessity of caution.
Baskys teaches:
wherein the metabolic information includes information on at least one of a metabolic rate, a medicine dosage, and necessity of caution (Paragraph [0027]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Valentine to disclose the metabolic information includes information on at least one of a metabolic rate, a medicine dosage, and necessity of caution as taught by Baskys. Valentine discloses a drug specific drug dispensing algorithm, and method to improve medication safety and effectiveness (Valentine Abstract). Using the database of drugs and nutraceuticals to search for drug metabolism of Baskys would provide the most effective prescription for the patient since metabolic rates are known to inversely correlate with the likelihood of drug-induced side effects. (Baskys Paragraph [0027]).
Regarding claim 17, Valentine does not explicitly disclose:
the online dispensing system according to claim 16, wherein the metabolic information includes at least one of information on a medicine metabolism rate, information on a medicine dosage, and information on necessity of caution corresponding to a gene polymorphism of the user.
Baskys teaches:
the online dispensing system according to claim 16, wherein the metabolic information includes at least one of information on a medicine metabolism rate, information on a medicine dosage, and information on necessity of caution corresponding to a gene polymorphism of the user (Paragraph [0027]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Valentine to disclose the online dispensing system according to claim 16, wherein the metabolic information includes at least one of information on a medicine metabolism rate, information on a medicine dosage, and information on necessity of caution corresponding to a gene polymorphism of the user as taught by Baskys. Valentine discloses a drug specific drug dispensing algorithm, and method to improve medication safety and effectiveness (Valentine Abstract). Using the database of drugs and nutraceuticals to search for drug metabolism of Baskys would provide the most effective prescription for the patient since metabolic rates are known to inversely correlate with the likelihood of drug-induced side effects. (Baskys Paragraph [0027]).
Regarding claim 18, Valentine discloses the online dispensing system according to claim 13, wherein the first information acquirer generates in advance, with respect to the user, list information of medicines likely to cause side effects when taken on the basis of genetic information of the user, and generates the first information with respect to medicines included in both the medicine information and the list information (Paragraph [0072]).
Regarding claim 19, Valentine discloses the online dispensing system according to claim 13, further comprising a setting information generator configured to generate setting information for causing the user terminal device to perform an operation according to content of the information presentation performed on the user by the presentation information input person, wherein the linkage processor acquires the content of the information presentation performed by the presentation information input person from the presentation information input terminal device, provides the content to the setting information generator, and provides the setting information generated by the setting information generator to the user terminal device (Paragraph [0085]).
Regarding claim 20, Valentine discloses the online dispensing system according to claim 19, further comprising an administration state monitor configured to monitor an administration state of the medicine from the user in response to a notification from the user terminal device wherein the setting information causes the presentation information input terminal device to perform an operation of notifying of an administration timing of the medicine, and causes the presentation information input terminal device to perform an operation of notifying the administration state monitor of the administration state of the medicine from the user (Paragraph [0089]).
Regarding claim 21, Valentine discloses the online dispensing system according to claim 20, wherein the administration state monitor provides supplementary information corresponding to the administration state of the user to the user terminal device on the basis of the administration state of the medicine notified from the user terminal device (Paragraph [0089]).
Regarding claim 22, Valentine discloses the online dispensing system according to claim 13, further comprising a second information acquirer configured to acquire second information on side effects of the medicine to be delivered to the user on the basis of the medicine information and medical checkup information of the user, wherein the linkage processor provides the first information and the second information as the side effect information to the presentation information input terminal device (Paragraph [0088]) .
Regarding claim 23, Valentine discloses the online dispensing system according to claim 22, wherein the second information acquirer detects an abnormal value in the medical checkup information of the user and generates the second information on the basis of the detection result (Paragraph [0102]).
Regarding claim 24, Valentine discloses the online dispensing system according to claim 23, wherein the abnormal value is an abnormal value with respect to a kidney function or a liver function (Paragraph [0074]; Table 3).
Regarding claim 25, Valentine discloses the online dispensing system according to claim 22, further comprising a third information acquirer configured to acquire third information on side effects likely to occur due to medicine combination of a plurality of medicines in a case where the medicine information includes the plurality of medicines prescribed to be taken at the same timing, wherein the linkage processor provides the first information, the second information, and the third information as the side effect information to the presentation information input terminal device (Paragraph [0018]).
Regarding claim 26, Valentine discloses the online dispensing system according to claim 25, wherein the third information includes information on side effects caused by a combination of past medicines of similar users (Paragraph [0149]).
Regarding claim 27, Valentine discloses the online dispensing system according to claim 26, further comprising a medication state database configured to store information indicating medication states including presence or absence of subjective symptoms due to medication of the user, wherein the third information acquirer acquires, from the medication information database, information on side effects caused by a combination of medicines in past medication of a user having the same genotype as the user with respect to the medicine prescribed to the user and includes the information in the third information (Paragraph [0022]).
Regarding claim 28, Valentine discloses the online dispensing system according to claim 25, wherein the third information includes relevance inference results obtained on the basis of learning results obtained by learning a relevance between combinations of past medicines of similar users and presence or absence of side effects by machine learning (Paragraph [0057]).
Regarding claim 29, Valentine discloses the online dispensing system according to claim 28, wherein the third information acquirer learns a relevance between combinations of medicines and presence or absence of side effects by machine learning on the basis of the genetic information of the user and past administration states of the user and the similar users accumulated in the medication state database, estimates presence or absence of side effects from the learning results, the genetic information and the medicine information of the user, and includes the estimation result in the third information (Paragraph [0171]).
Regarding claim 30, Valentine discloses An information linkage server comprising:
a genetic information server configured to store genetic information of a user (Paragraph [0079]: The listing for each drug includes by definition each drug's respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions);
a presentation information input terminal device used by a presentation information input person who performs information presentation with respect to a medicine to be delivered to the user (Paragraph [0088]: the Prescription module 80b, which is unique to the drug, encompasses the ability of the Prescriber 60, other authorized healthcare professionals, or the Integrated Support Center 40 to input the prescribing information into the Drug Specific App); and
a linkage processor configured to perform linkage of various types information with a user terminal device used by the user, wherein the linkage processor acquires medicine information on a medicine written in a prescription of the user from the presentation information input terminal device, provides the medicine information to the genetic information server, and provides first information on side effects of the medicine generated by the genetic information server on the basis of the medicine information to the presentation information input terminal device (Paragraphs [0091]: The Interface Device module 80d encompasses many functions: (i) home for the Drug Specific App 10, (ii) enables the Drug Specific App 10 to utilize the Interface Device features to facilitate the Drug Specific App's interface with the Patient, and [0099]: The Patient Reporting 80j module encompasses, as an example: (i) an ability by the Patient 50 to request certain reports, e.g., the last time the Patient 50 took the medication, prescription information details, drug details (brand and generics names, batch number, expiration date, doses remaining, reorder information, drug interactions, typical side effects).
Valentine discloses the limitations above. Valentine does not explicitly disclose:
wherein the linkage processor acquires metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored, and the first information includes the acquired metabolic information.
Baskys teaches:
wherein the linkage processor acquires metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored, and the first information includes the acquired metabolic information (Paragraphs [0030]: Upon receiving genetic data, the computer processor executes a code that causes the data to search a database of drugs and nutraceuticals whose effectiveness, side effect profile, metabolism or any other biological function may be affected by the mutation or mutations, and [0035]: These drugs and nutraceuticals may be entered separately by the user and the user can observe the changes in the plurality of the interactions between the prescription drugs or nutraceuticals and genetic data, and as a result become aware of potential adverse interactions or a loss of effectiveness of his or her current medications).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Valentine to disclose the linkage processor acquires metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored, and the first information includes the acquired metabolic information as taught by Baskys. Valentine discloses a drug specific drug dispensing algorithm, and method to improve medication safety and effectiveness (Valentine Abstract). Using the database of drugs and nutraceuticals to search for drug metabolism of Baskys would provide the most effective prescription for the patient since metabolic rates are known to inversely correlate with the likelihood of drug-induced side effects. (Baskys Paragraph [0027]).
Regarding claim 33, Valentine discloses the information linkage server according to claim 30, wherein the linkage processor further provides third information on side effects caused by a combination of past medicines of similar users to the presentation information input terminal device (Paragraph [0149]).
Regarding claim 34, Valentine discloses the information linkage server according to claim 33, wherein the linkage processor acquires information on side effects caused by a combination of medicines in past medication of a user who has the same genotype as the user with respect to the medicine prescribed to the user from a medication state database that stores information indicating medication states including presence or absence of subjective symptoms due to medication of the user, and includes the information in the third information (Paragraph [0171]).
Regarding claim 35, Valentine discloses An online dispensing method comprising:
acquiring first information on side effects of a medicine to be delivered to a user on the basis of medicine information on a medicine written in a prescription of the user and genetic information of the user (Paragraph [0079]: The listing for each drug includes by definition each drug's respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions); and
providing the first information as side effect information on the medicine to a presentation information input terminal device used by a presentation information input person who presents information to the user (Paragraph [0088]: the Prescription module 80b, which is unique to the drug, encompasses the ability of the Prescriber 60, other authorized healthcare professionals, or the Integrated Support Center 40 to input the prescribing information into the Drug Specific App), wherein the presentation information input terminal device supports execution of the information presentation through communication with a user terminal device used by the user and enables reference to the side effect information in the information presentation with respect to the information presentation of the medicine to be performed on the user when the pharmacist delivers the medicine (Paragraphs [0091]: The Interface Device module 80d encompasses many functions: (i) home for the Drug Specific App 10, (ii) enables the Drug Specific App 10 to utilize the Interface Device features to facilitate the Drug Specific App's interface with the Patient, and [0099]: The Patient Reporting 80j module encompasses, as an example: (i) an ability by the Patient 50 to request certain reports, e.g., the last time the Patient 50 took the medication, prescription information details, drug details (brand and generics names, batch number, expiration date, doses remaining, reorder information, drug interactions, typical side effects).
Valentine discloses the limitations above. Valentine does not explicitly disclose:
acquiring metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored, wherein the first information includes the acquired metabolic information.
Baskys teaches:
acquiring metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored, wherein the first information includes the acquired metabolic information (Paragraphs [0030]: Upon receiving genetic data, the computer processor executes a code that causes the data to search a database of drugs and nutraceuticals whose effectiveness, side effect profile, metabolism or any other biological function may be affected by the mutation or mutations, and [0035]: These drugs and nutraceuticals may be entered separately by the user and the user can observe the changes in the plurality of the interactions between the prescription drugs or nutraceuticals and genetic data, and as a result become aware of potential adverse interactions or a loss of effectiveness of his or her current medications).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Valentine to disclose acquiring metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored, wherein the first information includes the acquired metabolic information as taught by Baskys. Valentine discloses a drug specific drug dispensing algorithm, and method to improve medication safety and effectiveness (Valentine Abstract). Using the database of drugs and nutraceuticals to search for drug metabolism of Baskys would provide the most effective prescription for the patient since metabolic rates are known to inversely correlate with the likelihood of drug-induced side effects. (Baskys Paragraph [0027]).
Regarding claim 36, Valentine discloses a program causing a computer communicating with a genetic information server configured to store genetic information of a user, a presentation information input terminal device used by a presentation information input person who presents information on a medicine to be delivered to the user, and a user terminal device used by the user to:
acquire medicine information on the medicine written in a prescription of the user from the presentation information input terminal device and provide the medicine information to the genetic information server (Paragraph [0079]: The listing for each drug includes by definition each drug's respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions); and
provide information on side effects of the medicine generated by the genetic information server on the basis of the medicine information to the presentation information input terminal device (Paragraph [0088]: the Prescription module 80b, which is unique to the drug, encompasses the ability of the Prescriber 60, other authorized healthcare professionals, or the Integrated Support Center 40 to input the prescribing information into the Drug Specific App).
Valentine discloses the limitations above. Valentine does not explicitly disclose:
acquire metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored; and
wherein the information on side effects includes the acquired metabolic information.
Baskys teaches:
acquire metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored (Paragraphs [0030]: Upon receiving genetic data, the computer processor executes a code that causes the data to search a database of drugs and nutraceuticals whose effectiveness, side effect profile, metabolism or any other biological function may be affected by the mutation or mutations, and [0035]: These drugs and nutraceuticals may be entered separately by the user and the user can observe the changes in the plurality of the interactions between the prescription drugs or nutraceuticals and genetic data, and as a result become aware of potential adverse interactions or a loss of effectiveness of his or her current medications); and
wherein the information on side effects includes the acquired metabolic information (Paragraph [0030].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Valentine to disclose acquire metabolic information on medicine metabolism on the medicine written in the prescription of the user from a medicine metabolism database in which the metabolic information for each medicine is stored; and wherein the information on side effects includes the acquired metabolic information as taught by Baskys. Valentine discloses a drug specific drug dispensing algorithm, and method to improve medication safety and effectiveness (Valentine Abstract). Using the database of drugs and nutraceuticals to search for drug metabolism of Baskys would provide the most effective prescription for the patient since metabolic rates are known to inversely correlate with the likelihood of drug-induced side effects. (Baskys Paragraph [0027]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHINYERE MPAMUGO whose telephone number is (571)272-8853. The examiner can normally be reached Monday-Friday, 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHINYERE MPAMUGO/Primary Examiner, Art Unit 3685
Prosecution Insights