DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/01/2026 has been entered.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In light of the amendments, the previous claim objection has been withdrawn.
In light of the amendments, the previous claim 112(b) rejections are withdrawn.
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, claims 4-6 are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 05/01/2026, the following has occurred: claims 1, 4, and 18-19 have been amended; claims 2-3, 5-6, and 16-17 remain unchanged; claims 7-15 have been canceled; and no new claims have been added.
Claims 1-6 and 16-19 are pending.
Effective Filing Date: 03/31/2020
Response to Arguments
Claim Objection:
Applicant amended the claims to overcome the previous claim objections. Examiner withdraws these objections.
35 U.S.C. 112(b) Rejections:
Applicant amended the claims to overcome the previous claim rejections. Examiner withdraws these rejections.
35 U.S.C. 101 Rejections:
Applicant argues that there is an improvement to a technology and points to both the conventional approaches in the specification and Intellectual Ventures. Applicant further states that there is an improved technique to dispensing medication involving a two-tiered consent approach. Examiner however respectfully disagrees that managing consent in a two-tiered manner is a technical improvement, rather, it is an improvement to an abstract idea.
Additionally, Applicant argues that the dispensing of medicine as recite in the pending claims is analogous to the opening of the press in Diamond v Diehr. Examiner however respectfully disagrees. Initially, there is no dispensing of the medicine in independent claims 1 and 4. The recitation in claim 1 is not analogous in that there only needs to be a device which is configured to dispense the medicine. The medicine is not actively being dispensed, whereas the press in Diamond v Diehr is actively being opened. Claim 19 does however recite an active dispensing step, however it is a method claim and it does not exclusively recite that the dispensing is occurring in an automated fashion without human intervention.
35 U.S.C. 103 Rejections:
Applicant argues that the amended claim language overcomes the art rejections. Examiner however has addressed the new claim limitations using the newly-cited Iantorno et al. reference.
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 1-6 and 16-19 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. Claims 1-3 and 16-18 are drawn to a system, claims 4-6 are drawn to an apparatus, and claim 19 is drawn to a method, each of which are within the four statutory categories. Claims 1-6 and 16-19 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites an information provision system comprising a) an information providing apparatus and b) an information managing apparatus and c) a dispensing device, wherein the information managing apparatus comprising:
b1) a storage device that stores user gene information that is information relating to a gene of a user and caution medicine information indicating a medicine requiring caution in use for the user, the caution medicine information being obtained based on the user gene information,
b2) a processor, and
b3) a storage medium having computer program instructions stored thereon, wherein the computer program instructions, when executed by the processor, perform to:
1) determine whether primary consent to share caution medicine information for the user has been received from the user; and
2) transmit the caution medicine information over a network to the information providing apparatus on the condition that the primary consent has been obtained from the user;
and the information providing apparatus comprising:
a1) a processor; and
a2) a storage medium having computer program instructions stored thereon, when executed by the processor, perform to:
3) receive the caution medicine information from the information managing apparatus;
4) receive prescription information indicating a medicine prescribed for the user;
5) determine whether medicine indicated in the caution medicine information matches the medicine prescribed for the user;
6) add alert information to the prescription information in response to a determination that the medicine indicated in the caution medicine information matches the medicine prescribed for the user;
7) transmit the prescription information via the network to the dispensing device;
wherein the information managing apparatus further performs to:
8) receive secondary consent to share information indicating a gene of the user from the user, where the secondary consent differs from the primary consent;
9) transmit gene-related information for the user to the dispensing device in response to receiving the secondary consent from the user, where the gene-related information includes information for genes of the user that cause the medicine to require caution; and
the dispensing device configured to 10) receive the gene-related information and dispense the medicine taking into account the gene-related information.
From above, claim 1 recites, in part, the following steps: 1) determine whether primary consent to share caution medicine information for the user has been received from the user, 2) transmit the caution medicine information over a network on the condition that the primary consent has been obtained from the user, 3) receive the caution medicine information, 4) receive prescription information indicating a medicine prescribed for the user, 5) determine whether medicine indicated in the caution medicine information matches the medicine prescribed for the user, 6) add alert information to the prescription information in response to a determination that the medicine indicated in the caution medicine information matches the medicine prescribed for the user, 7) transmit the prescription information via the network, 8) receive secondary consent to share information indicating a gene of the user from the user, where the secondary consent differs from the primary consent, 9) transmit gene-related information for the user in response to receiving the secondary consent from the user, where the gene-related information includes information for genes of the user that cause the medicine to require caution, and 10) receive the gene-related information and dispense the medicine taking into account the gene-related information. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes determining and sharing warning information for a patient for their dispensed medication. Claim 19 is similar to claim 1 and the same analysis applies to it.
Claim 4 recites b) an information managing apparatus comprising:
b1) a storage device that stores user gene information that is information relating to a gene of a user and caution medicine information indicating a medicine requiring caution in use for the user, the caution medicine information being obtained based on the user gene information;
b2) a processor; and
b3) a storage medium having computer program instructions stored thereon, wherein the computer program instructions, when executed by the processor, perform to:
1) determine whether primary consent to share caution medicine information for the user has been received from the user; and
2) transmit the caution medicine information over a network to an information providing apparatus on the condition that the primary consent has been obtained from the user,
wherein the information managing apparatus further performs to:
8) receive secondary consent to share information indicating a gene of the user from the user, where the secondary consent differs from the primary consent;
9) transmit gene-related information for the user to c) a dispensing device in response to receiving the secondary consent from the user, where the gene-related information includes information for genes of the user that cause the medicine to require caution.
From above, claim 4 recites, in part, the following steps: 1) determine whether primary consent to share caution medicine information for the user has been received from the user, 2) transmit the caution medicine information over a network to an information providing apparatus on the condition that the primary consent has been obtained from the user, 8) receive secondary consent to share information indicating a gene of the user from the user, where the secondary consent differs from the primary consent, and 9) transmit gene-related information for the user in response to receiving the secondary consent from the user, where the gene-related information includes information for genes of the user that cause the medicine to require caution. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes determining and sharing warning information for a patient for their dispensed medication.
Depending claims 2-3, 5-6, and 16-18 include all of the limitations of claims 1 and 4, and therefore likewise incorporate the above described abstract idea. Depending claim 3 adds the additional step of “provide information indicating another medicine that is usable as an alternative medicine for the medicine in addition to the information relating a medicine requiring caution in use for the user”; claim 5 adds the additional step of “provide a part or an entirety of the user gene information to the other device subject to a predetermined condition indicating obtainment of consent from the user being met”; claim 6 adds the additional step of “for each user, generate the caution medicine information based on the user gene information”; and claim 16 adds the additional steps of “transmit the caution medicine information to the information providing apparatus, only for a user whose primary consent has been obtained” and “transmit the gene-related information to the another device, for a user whose primary consent has been obtained and whose secondary consent has subsequently been obtained”. Additionally, the limitations of depending claims 2 and 17-18 further specify elements from the claim from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-3, 5-6, and 16-18 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 4 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) the information providing apparatus comprising: a1) a processor, and a2) a storage medium having computer program instructions stored thereon, when executed by the processor, perform functions, b) the information managing apparatus comprising: b1) a storage device that stores user gene information that is information relating to a gene of a user and caution medicine information indicating a medicine requiring caution in use for the user, the caution medicine information being obtained based on the user gene information, b2) a processor, and b3) a storage medium having computer program instructions stored thereon, wherein the computer program instructions, when executed by the processor, perform functions, c) a dispensing device, and d) another device to perform the claimed steps.
The a) information providing apparatus comprising: a1) a processor, and a2) a storage medium having computer program instructions stored thereon, when executed by the processor, perform functions and b) the information managing apparatus comprising: b1) a storage device that stores user gene information that is information relating to a gene of a user and caution medicine information indicating a medicine requiring caution in use for the user, the caution medicine information being obtained based on the user gene information, b2) a processor, and b3) a storage medium having computer program instructions stored thereon, wherein the computer program instructions, when executed by the processor, perform functions, and in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, paragraphs [0046] – [0050] where there are generic components provided, see MPEP 2106.05(f)).
The c) dispensing device and d) another device in these steps add insignificant extra-solution activity to the abstract idea which amounts to insignificant application, see MPEP 2106.05(g).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements listed above. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
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. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements 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 elements of using a) the information providing apparatus comprising: a1) a processor, and a2) a storage medium having computer program instructions stored thereon, when executed by the processor, perform functions, b) the information managing apparatus comprising: b1) a storage device that stores user gene information that is information relating to a gene of a user and caution medicine information indicating a medicine requiring caution in use for the user, the caution medicine information being obtained based on the user gene information, b2) a processor, and b3) a storage medium having computer program instructions stored thereon, wherein the computer program instructions, when executed by the processor, perform functions, c) a dispensing device, and d) another device to perform the claimed steps amounts to no more than insignificant extra-solution activity in the form of WURC activity (well-understood, routine, and conventional activity) and mere instructions to apply the exception using generic computer components that does not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(d) and MPEP 2106.05(f) recite that the following limitations are not significantly more:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)); and
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention generates displays caution data using a) the information providing apparatus comprising: a1) a processor, and a2) a storage medium having computer program instructions stored thereon, when executed by the processor, perform functions and b) the information managing apparatus comprising: b1) a storage device that stores user gene information that is information relating to a gene of a user and caution medicine information indicating a medicine requiring caution in use for the user, the caution medicine information being obtained based on the user gene information, b2) a processor, and b3) a storage medium having computer program instructions stored thereon, wherein the computer program instructions, when executed by the processor, perform functions, thus these components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Furthermore, the c) dispensing device and d) another device in these steps add insignificant extra-solution activity/pre-solution activity in the form of WURC activity to the abstract idea. The following is an example of a court decision demonstrating computer functions as well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II): Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives caution data, and transmits the data to the another device/dispensing device over a network, for example the Internet.
Mere instructions to apply an exception using generic computer components or insignificant extra-solution activity in the form of WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-6 and 16-19 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0348158 to Livesay et al. in view of U.S. 2020/0135314 to Gostyla et al. and further in view of U.S. 2021/0074416 to Iantorno et al.
As per claim 4, Livesay et al. teaches an information managing apparatus comprising:
--a processor; (paragraph [0109] where there is a processor) and
--a storage medium having computer program instructions stored thereon, (see: paragraph [0109] where there is a memory with instructions) wherein the computer program instructions, when executed by the processor, perform to:
--determine whether primary consent to share caution medicine information for the user has been received from the user; (see: paragraph [0002] where there is a determination on whether to share the information of the user. This shared information can also include allergy information and medication information as stated in paragraph [0120]) and
--transmit the caution medicine information over a network to an information providing apparatus on the condition that the primary consent has been obtained from the user, (see: paragraph [0008] where there is sharing of a patient’s information over a network based on the primary consent)
--wherein the information managing apparatus further performs to:
--receive secondary consent to share information indicating a type of information of the user from the user, where the secondary consent differs from the primary consent; (see: paragraph [0066] where there are different consents for various type of health information and for various type of organizations. A secondary consent is being received here to specify health information here)
--transmit gene-related information for the user to a device in response to receiving the secondary consent from the user (see: paragraph [0096] where information is being transmitted to another device once consent is received).
Livesay et al. fails to further, specifically teach:
1) --type of information as gene information;
2) --a dispensing device as a device; and
3) --where the gene-related information includes information for genes of the user that cause the medicine to require caution.
Gostyla et al. teaches:
1) --type of information as gene information; (see: paragraph [0007] where there is gene information as a type of information. Also, there is gene-related information as a type of information. This information includes medication-to-gene information which indicates which medicine should be cautioned for that user) and
3) --where the gene-related information includes information for genes of the user that cause the medicine to require caution (see: paragraph [0007] where there is gene information as a type of information. Also, there is gene-related information as a type of information. This information includes medication-to-gene information which indicates which medicine should be cautioned for that user).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have 3) where the gene-related information includes information for genes of the user that cause the medicine to require caution as taught by Gostyla et al. in the apparatus as taught by Livesay et al. with the motivation(s) of providing up-to-date information to help the patient (see: paragraph [0003] of Gostyla et al.).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 1) gene or gene-related information as taught by Gostyla et al. for the type of information as disclosed by Livesay et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Livesay et al. teaches of sharing different type of patient information thus it would be obvious to replace one type of information for another type of information as predictable results of sharing patient information would be achieved. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Iantorno et al. teaches:
2) --a dispensing device as a device (see: paragraph [0006] where there is an apparatus for storing and dispensing medications).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 2) a dispensing device as taught by Iantorno et al. for the device as disclosed by Livesay et al. and Gostyla et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Livesay et al. and Gostyla et al. in combination teaches of sending information to a device thus one could switch that type of device for another type of device and achieve predictable results of using a device. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 6, Livesay et al., Gostyla et al., and Iantorno et al. in combination teaches the apparatus of claim 4, see discussion of claim 4. Gostyla et al. further teaches wherein the computer program instructions of the information managing apparatus further perform to, for each user, generate the caution medicine information based on the user gene information (see: paragraph [0071] where there is generation of caution information (allergy, etc.) based on the gene information).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 4, and incorporated herein.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0348158 to Livesay et al. in view of U.S. 2020/0135314 to Gostyla et al. and further in view of U.S. 2021/0074416 to Iantorno et al. as applied to claim 1, and further in view of U.S. 2020/0286634 to Takahata et al.
As per claim 5, Livesay et al., Gostyla et al., and Iantorno et al. in combination teaches the apparatus of claim 4, see discussion of claim 4. The combination may not further, specifically teach wherein the computer program instructions of the information managing apparatus further perform to provide a part or an entirety of the user gene information to the other device subject to a predetermined condition indicating obtainment of consent from the user being met.
Takahata et al. teaches:
--wherein the computer program instructions of the information managing apparatus further perform to provide a part or an entirety of the user gene information to the other device subject to a predetermined condition indicating obtainment of consent from the user being met (see: paragraph [0238] where there is a consent of a patient which is given, and accordingly, access to genetic information is given in the form of anonymized test results shared to a third party institution. The third party has a device here which enables them to view this information as explained in paragraph [0008]).
One of ordinary skill at the time of the invention was filed would have found it obvious to have wherein the computer program instructions of the information managing apparatus further perform to provide a part or an entirety of the user gene information to the other device subject to a predetermined condition indicating obtainment of consent from the user being met as taught by Takahata et al. in the apparatus as taught by Livesay et al., Gostyla et al., and Iantorno et al. in combination with the motivation(s) of being helpful when determining a treatment policy suitable for each patient (see: paragraph [0004] of Takahata et al.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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