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 .
DETAILED ACTION
In the amendment filed 17 March 2026.
Claims 1, 12, 14-15, and 19-20 are amended
Claims 1-20 are pending
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 1-20 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, 15, 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a system, method and non-transitory computer-readable medium, which are within a statutory category.
Step 2A1
The limitations of:
Claims 1, 15, 20 (Claim 20 being representative)
storing, in the storage:
a plurality of data entities that each store data for a particular substance;
and a plurality of substitution groups each assigned a subset of the plurality of data entities and including a substitution configuration, the plurality of substitution groups including a first substitution group, the first substitution group:
assigned a first subset of data entities sharing a common active ingredient of respective substances, the first subset of data entities including a first data entity storing data for a first substance and a second data entity storing data for a second substance;
and including a first substitution configuration indicating a first instruction for the first data entity, wherein execution of the first instruction replaces the first data entity with the second data entity in a generated order template;
and generating a first order template in response to input requesting generation of a first order for the first substance, the first order template indicating a first data entity of a first subset of data entities assigned to a first substitution group of a plurality of substitution groups, the first subset of data entities sharing a common active ingredient of respective substances, wherein:
the first subset of data entities includes the first data entity storing information for a first substance and a second data entity storing data for a second substance;
and the first substitution group includes a first substitution configuration indicating a first instruction for the first data entity, wherein execution of the first instruction replaces the first data entity with the second data entity in a generated order template;
determining that the first data entity is assigned to the first substitution group;
in response to determining that the first data entity is assigned to the first substitution group in the memory, execute the first instruction for the first data entity prior to the persistence of the first order in the HER system, the execution comprising:
modifying the first order template based on the first data entity substitution configuration at least in part by replacing the first data entity indicated by the first order template with the second data entity to obtain a modified first order template;
and persisting the first order by storing information, in the first order, from the second data entity indicated by the modified first order template instead of information from the first data entity such that the second substance is substituted in place of the first substance in the first order,
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to find alternative medication in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “retrieving…identifying…determining…and causing display” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a system implemented by a data processor (computer), the claimed invention amounts to managing personal behavior or interaction between people.. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a data processing system comprising a computer hardware processor and memory, EHR system and non-transitory computer-readable medium that implements the identified abstract idea. The data processing system comprising a computer hardware processor and memory, EHR system and non-transitory computer-readable medium are not described by the applicant and is recited at a high-level of generality (i.e., a generic computer performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do 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.
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 data processing system comprising a computer hardware processor and memory, EHR system and non-transitory computer-readable medium to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Claims 2-14,16-19 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 16 merely describe(s) accessing and using reference data, which further defines the abstract idea.
Claim(s) 3, 17 merely describe(s) identifying data entities, which further defines the abstract idea.
Claim(s) 4, 18 merely describe(s) presenting data and receiving user input, which further defines the abstract idea.
Claim(s) 4, 18 also includes the additional element of “graphical user interface” which generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim(s) 5,19 merely describe(s) storing, mapping and identifying active ingredient data, which further defines the abstract idea.
Claim(s) 6 merely describe(s) receiving and updating data, which further defines the abstract idea.
Claim(s) 7 merely describe(s) substituting delivery method data, which further defines the abstract idea.
Claim(s) 8 merely describe(s) modifying template data, which further defines the abstract idea.
Claim(s) 9 merely describe(s) what the substitution configuration contains, which further defines the abstract idea.
Claim(s) 10 merely describe(s) obtaining, accessing and modifying medication data for a patient, which further defines the abstract idea.
Claim(s) 11 merely describe(s) what the substitution groups contain, which further defines the abstract idea.
Claim(s) 12 merely describe(s) obtaining, accessing and modifying medication data for a patient, which further defines the abstract idea.
Claim(s) 13 merely describe(s) what the substitution configuration contains, which further defines the abstract idea.
Claim(s) 14 merely describe(s) receiving and updating data, which further defines the abstract idea.
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 Examiner notes that the rejection will reference the translated documents (attached) corresponding to any foreign documents recited in the rejection.
Claims 1-3,5-17,19-20 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Arends et al (US Publication No. 11676692) in view of BROUSSARD et al (Foreign Publication WO-2004036481-A2).
Regarding Claim 1
Arends teacher a data processing system for automatically substituting drug information into orders generated in an electronic health record (EHR) system prior to the orders being persisted in storage of the EHR system, the data processing system comprising:
a computer hardware processor [Arends at Para. 96 teaches in example embodiments, one or more computer systems (e.g., a standalone, client or server computer system) or one or more hardware modules of a computer system (e.g., a processor or a group of processors) may be configured by software (e.g., an application or application portion) as a hardware module that operates to perform certain operations as described herein];
and memory storing [Arends at Para 99 teaches a further hardware module may then, at a later time, access the memory device to retrieve and process the stored output]:
a plurality of data entities that each store data for a particular substance [Arends at Para. 0087 teaches returning now to the system of FIGS. 1, 2 and 3 that includes the ability to provide the EDS to the patient as depicted in FIG. 4, the healthcare data processing system draws its data from two principal databases, the ePR (pharmaceutical data) and EPO data (standardized healthcare data) databases, both of which contain volumes of data formatted in disparate configurations from multiple sources.];
a plurality of substitution groups each assigned a subset of the plurality of data entities and including a substitution configuration, the plurality of substitution groups including a first substitution group, the first substitution group [Arends at Para. 61 teaches the processor 162 may execute the medication data receiving module 545a to, for example, cause the processor 162 to receive medication data (block 545b). For example, the processor 162 may receive medication data from learning directory 213 of FIG. 2, a drug information compendia 229 of FIG. 2, a patient safety network 260 of FIG. 2, etc. The medication data may be, for example, representative of therapeutic equivalency (TE) codes (e.g., TE codes in the orange book that signify pharmaceutical equivalents that are bioequivalent), pharmaceutical equivalents drug products which contain the same active ingredients in the same strength and dosage form delivered by the same route of administration, bioequivalent drug products that have shown comparable bioavailability when studied under similar conditions (e.g., the rate and extent of absorption of a test drug does not significantly differ from that of the reference drug), etc];
assigned a first subset of data entities sharing a common active ingredient of respective substances, the first subset of data entities including a first data entity storing data for a first substance and a second data entity storing data for a second substance [Arends at Para. 61];
and including a first substitution configuration indicating a first instruction for the first data entity, wherein execution of the first instruction replaces the first data entity with the second data entity in a generated order template [Arends at Para. 114 teaches the prescriber message may be representative of a request to have the prescriber replace the medication included within the electronic prescription data with the alternate medication];
and instructions that, when executed by the computer hardware processor, cause the computer hardware processor to:
generate a first order template in response to input requesting generation of a first order for the first substance in the EHR system, the first order template indicating the first data entity of the first subset of data entities assigned to the first substitution group [Arends at Para. 34 teaches Generally speaking, an automated pharmacy processing system (also referred to herein as “the system”) receives an electronic prescription from a health care organization using electronic medical records (EMRs), electronic health records (EHRs), or standalone e-Prescribing systems. The system automatically converts the information from the electronic prescription into a pharmacy prescription record, which can be filled by a pharmacist at a selected pharmacy location, without requiring a technician to manually enter data from the electronic prescription into the pharmacy processing system. The automated pharmacy processing system may convert patient identification information, prescribing physician (also referred to herein as a “prescriber”) identification information, medication information, drug quantity, drug days' supply and directions for use (Sig) from an electronic prescription format into the pharmacy prescription record. In addition, the automated pharmacy processing system may determine whether generic substitution of a brand name medication is allowed and substitutes the generic for the brand name medication on the electronic prescription];
determine that the first data entity is assigned to the first substitution group in the memory Arends at Para. 34];
modify the first order template based on the first substitution configuration at least in part by replacing the first data entity indicated by the first order template with the second data entity to obtain a modified first order template [Arends at Para. 34 teaches in addition, the automated pharmacy processing system may determine whether generic substitution of a brand name medication is allowed and substitutes the generic for the brand name medication on the electronic prescription];
Arends does not teach in response to determining that the first data entity is assigned to the first substitution group in the memory, execute the first instruction for the first data entity prior to the persistence of the first order in the EHR system, the execution comprising:
and persist, in the EHR system, the first order by storing information, in the first order, from the second data entity indicated by the modified first order template instead of information from the first data entity such that the second substance is substituted in place of the first substance in the first order.
BROUSSARD teaches in response to determining that the first data entity is assigned to the first substitution group in the memory, execute the first instruction for the first data entity [BROUSSARD at Para. 0079 teaches at operation 222, various substitution rules begin to be applied to the selected drug. It is anticipated that the substitution rules will likely be applied in some hierarchical manner. Rules that do not permit substitution, even though alternative medical items have been identified, may be applied first. For example, an insurance carrier may have a policy of not paying for certain drugs, even though they have been designated within the integrated pharmacy system 10 as equivalent. Thus, those rules would be applied first to determine if substitution is allowed] prior to the persistence of the first order in the EHR system [BROUSSARD at Para. 0075 teaches operation 210A in FIG. 3 A represents either a manual dispense or an automated dispense, or some combination thereof, which occurs in response to the dispensing information output by operation 208 A. After a drug has been dispensed in operation 210A, a verification may be completed in operation 212A to insure that the drug actually dispensed is the drug selected from the substitution reference list. Once the fulfillment process has been completed and checked in operation 212A, a transaction data record is created and information related to the dispensing transaction is recorded in operation 214A], the execution comprising:
and persist, in the EHR system, the first order by storing information, in the first order, from the second data entity indicated by the modified first order template instead of information from the first data entity such that the second substance is substituted in place of the first substance in the first order [BROUSSARD at Para. 0047 teaches the check workstation 18 may also be used to create updated records should an equivalent medical item be substituted and dispensed].
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of the healthcare data with teaching of BROUSSARD since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the transaction data of the BROUSSARD for the healthcare records of Arends. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine data of Arends with the prior to persistence of BROUSSARD with the motivation to improve the level of customer service by proactively counseling the customer 32 [BROUSSARD at Para. 66].
Regarding Claim 2
Arends/BROUSSARD teach the data processing system of claim 1,
Arends/BROUSSARD further teach wherein the computer hardware processor is further configured to generate the first substitution group by performing: access a reference data entity storing information about a reference substance, the reference data entity indicating a particular active ingredient of the reference substance ;identify, from among the plurality of data entities, data entities based on the reference data entity, the identifying comprising identifying data entities that indicate the particular active ingredient of the reference substance; and assign at least some of the identified data entities to the first substitution group [Arends at Para. 61 (see Claim 1 for explanation)].
Regarding Claim 3
Arends/BROUSSARD teach the data processing system of claim 2,
Arends/BROUSSARD further teach wherein the reference data entity further indicates a particular delivery route of the reference substance and identifying, from among the plurality of data entities, the data entities based on the reference data entity further comprises: identifying data entities that indicate the particular delivery route of the reference substance in addition to the particular active ingredient of the reference substance [Arends at Para. 61 (see Claim 1 for explanation)].
Regarding Claim 5
Arends/BROUSSARD teach the data processing system of claim 2,
Arends/BROUSSARD further teach wherein: the memory stores data mapping the reference data entity to a set of data entities indicating the particular active ingredient of the reference substance; and identifying data entities that indicate the particular active ingredient of the reference substance comprises identifying, in the memory, the set of data entities mapped to the reference data entity [Arends at Para. 61 (see Claim 1 for explanation)].
Regarding Claim 6
Arends/BROUSSARD teach the data processing system of claim 5,
Arends/BROUSSARD further teach wherein the computer hardware processor is further configured to: receive a third data entity storing data associated with a third substance, the third data entity indicating the particular active ingredient of the reference substance; and after receiving the third data entity, update the data in the memory to map the reference data entity to the third data entity [BROUSSARD at Para. 0047 teaches the check workstation 18 may also be used to create updated records should an equivalent medical item be substituted and dispensed.].
Regarding Claim 7
Arends/BROUSSARD teach the data processing system of claim 1,
Arends/BROUSSARD further teach wherein the first data entity substitution configuration further comprises:a first delivery override, the first delivery override indicating that a first delivery method corresponding to the first data entity is to be overridden by a second delivery method when the second data entity is substituted into an order template [Arends at Para. 80 teaches an associated drug utilization review may enable medication changes and/or drug selection along with prescriber instruction generation Rx change use cases and directions clarification, and dose confirmation when different than previous therapy (use cases and directions clarification interpreted as delivery method)].
Regarding Claim 8
Arends/BROUSSARD teach the data processing system of claim 7,
Arends/BROUSSARD further teach wherein the instructions further cause the computer hardware processor to: modify the first order template based on the first data entity configuration associated with the first substitution group at least in part by changing the first delivery method to the second delivery method [Arends at Para. 34 teaches in addition, the automated pharmacy processing system may determine whether generic substitution of a brand name medication is allowed and substitutes the generic for the brand name medication on the electronic prescription (substitution interpreted to include change in direction clarification)].
Regarding Claim 9
Arends/BROUSSARD teach the data processing system of claim 1,
Arends/BROUSSARD further teach wherein the first data entity substitution configuration further includes a data entity override that overrides the instruction to substitute the second data entity in place of the first data entity, wherein the data entity override specifies a particular data entity to use when a target subject in an order template has a particular attribute [BROUSSARD at Para. 0078 teaches during operation 221 , the technician/pharmacist's 30 security level may be checked to insure that an override of the automatically selected drug is authorized. If an override is permitted, the technician's/pharmacist's 30 specific override frequency may be checked to confirm that they have not exceeded a pre-defined level. If the override is permissible, the prescription fulfillment process is allowed to continue, although the transaction is logged in the database for purposes of permitting review and creating an audit trail; BROUSSARD at Para. 0079 teaches at operation 222, various substitution rules begin to be applied to the selected drug. It is anticipated that the substitution rules will likely be applied in some hierarchical manner. Rules that do not permit substitution, even though alternative medical items have been identified, may be applied first. For example, an insurance carrier may have a policy of not paying for certain drugs, even though they have been designated within the integrated pharmacy system 10 as equivalent. Thus, those rules would be applied first to determine if substitution is allowed].
Regarding Claim 10
Arends/BROUSSARD teach the data processing system of claim 9,
Arends/BROUSSARD further teach wherein the instructions further cause the computer hardware processor to:
obtain a second order template generated by the EHR system for a first target subject, the second order template indicating the first data entity of the first subset of data entities assigned to the first substitution group [Arends at Para. 34 (see Claim 1 for explanation)];
access the first data entity substitution configuration associated with the first substitution group;
modify the second order template based on the first data entity substitution configuration at least in part by:
determining that the first target subject has the particular attribute specified by the data entity override of the first data entity substitution configuration [Arends at Para. 34 (see Claim 1 for explanation; interpret to combine with attributes of BROUSSARD)];
and when it is determined that the first target subject has the particular attribute specified by the data entity override, replacing the first data entity indicated by the second order template with the particular data entity to obtain a modified second order template [Arends at Para. 34 (see Claim 1 for explanation; interpret to combine with attributes of BROUSSARD)];
and persist, in the storage of the data record system, a second order storing information from the particular data entity indicated by the modified second order template [BROUSSARD at Para. 0047 (see Claim 1 for explanation)].
Regarding Claim 11
Arends/BROUSSARD teach the data processing system of claim 1,
Arends/BROUSSARD further teach wherein: the substitution groups include a second substitution group assigned a second subset of the plurality of data entities that store data associated with a set of biosimilar substances, the second substitution group including a second data entity substitution configuration [Arends at Para. 61 (see Claim 1 for explanation)].
Regarding Claim 12
Arends/BROUSSARD teach the data processing system of claim 11,
Arends/BROUSSARD further teach wherein the instructions further cause the computer hardware processor to perform:
obtain a second order template generated by the EHR system, the second order template indicating a third data entity of the second subset of data entities assigned to the second substitution group [Arends at Para. 34 (see Claim 1 for explanation)];
access the second data entity substitution configuration associated with the second substitution group, the second data entity substitution configuration indicating an instruction to substitute a fourth data entity of the second subset of data entities assigned to the second substitution group in place of the third data entity [Arends at Para. 34 (see Claim 1 for explanation)];
modify the second order template based on the second data entity substitution configuration at least in part by replacing the third data entity indicated by the second order template with the fourth data entity to obtain a modified second order template [Arends at Para. 34 (see Claim 1 for explanation)];
and persist, in the data storage of the EHR system, a second order storing information from the fourth data entity indicated by the modified second order template [BROUSSARD at Para. 0047 (see Claim 1 for explanation)].
Regarding Claim 13
Arends/BROUSSARD teach the data processing system of claim 12,
Arends/BROUSSARD further teach wherein the second data entity substitution configuration further includes a second data entity override that overrides the instruction to substitute the fourth data entity in place of the third data entity, wherein the second data entity override specifies a particular data entity to use when a target subject in an order template has a particular attribute.
Regarding Claim 14
The data processing system of claim 1, wherein the instructions, when executed by the computer hardware processor cause the computer hardware processor to:update at least one previously persisted order in the storage of the EHR system using information from the second data entity indicated by the modified first order template [Arends at Para. 113 (see Claim 4 for explanation)].
Regarding Claim 15
Arend teaches A method for automatically substituting information into orders generated in an electronic health record (EHR) system prior to the orders being persisted in storage of the EHR system, the method comprising:
using a computer hardware processor to perform [Arend at Para 39 teaches the EMR data storage entity 190 may include one or more data storage devices of any known non-transitory, tangible, computer-readable storage media technology (e.g., disks, solid state devices, data banks, servers, cloud storage, etc.). The central processing system 140 or the facility servers 126 may receive the electronic prescriptions 192 via the digital network 130.]:
storing, in the storage of the EHR system [Arend at Para 39]:
a plurality of data entities that each store data for a particular substance [Arends at Para. 0087 (see Claim 1 for explanation)];
and a plurality of substitution groups each assigned a subset of the plurality of data entities and including a substitution configuration, the plurality of substitution groups including a first substitution group, the first substitution group [Arends at Para. 0061 (see Claim 1 for explanation)]:
assigned a first subset of data entities sharing a common active ingredient of respective substances, the first subset of data entities including a first data entity storing data for a first substance and a second data entity storing data for a second substance [Arends at Para. 0061 (see Claim 1 for explanation)];
and including a first substitution configuration indicating a first instruction for the first data entity, wherein execution of the first instruction replaces the first data entity with the second data entity in a generated order template [Arends at Para. 0114 (see Claim 1 for explanation)];
and generating a first order template in response to input requesting generation of a first order for the first substance in the EHR system, the first order template indicating a first data entity of a first subset of data entities assigned to a first substitution group of a plurality of substitution groups, the first subset of data entities sharing a common active ingredient of respective substances, wherein [Arends at Para. 0034 (see Claim 1 for explanation)]:
the first subset of data entities includes the first data entity storing information for a first substance and a second data entity storing data for a second substance [Arends at Para. 0061 (see Claim 1 for explanation)];
and the first substitution group includes a first substitution configuration indicating a first instruction for the first data entity, wherein execution of the first instruction replaces the first data entity with the second data entity in a generated order template [Arends at Para. 0114 (see Claim 1 for explanation)];
determining that the first data entity is assigned to the first substitution group in the memory [Arends at Para. 0034 (see Claim 1 for explanation)];
modifying the first order template based on the first data entity substitution configuration at least in part by replacing the first data entity indicated by the first order template with the second data entity to obtain a modified first order template [Arends at Para. 0061 (see Claim 1 for explanation)];
Arends does not teach in response to determining that the first data entity is assigned to the first substitution group in the memory, execute the first instruction for the first data entity prior to the persistence of the first order in the EHR system, the execution comprising:
and persisting, in the EHR system, the first order by storing information, in the first order, from the second data entity indicated by the modified first order template instead of information from the first data entity such that the second substance is substituted in place of the first substance in the first order.
BROUSSARD teaches in response to determining that the first data entity is assigned to the first substitution group in the memory, execute the first instruction for the first data entity [BROUSSARD at Para. 0079 (see Claim 1 for explanation)] prior to the persistence of the first order in the EHR system, the execution comprising [BROUSSARD at Para. 0075 (see Claim 1 for explanation)]:
and persisting, in the EHR system, the first order by storing information, in the first order, from the second data entity indicated by the modified first order template instead of information from the first data entity such that the second substance is substituted in place of the first substance in the first order [BROUSSARD at Para. 0047 (see Claim 1 for explanation)].
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of the healthcare data with teaching of BROUSSARD since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the transaction data of the BROUSSARD for the healthcare records of Arends. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine data of Arends with the prior to persistence of BROUSSARD with the motivation to improve the level of customer service by proactively counseling the customer 32 [BROUSSARD at Para. 66].
Regarding Claim 16
Arends/BROUSSARD teach the data processing system of claim 15,
Arends/BROUSSARD further teach further comprising generating the first substitution group by performing: accessing a reference data entity storing information about a reference substance, the reference data entity indicating a particular active ingredient of the reference substance; identifying, from among the plurality of data entities, data entities based on the reference data entity, the identifying comprising identifying data entities that indicate the particular active ingredient of the reference substance; and assigning at least some of the identified data entities to the first substitution group [Arends at Para. 61 (see Claim 1 for explanation)].
Regarding Claim 17
Arends/BROUSSARD teach the data processing system of claim 16,
Arends/BROUSSARD further teach wherein the reference data entity further indicates a particular delivery route of the reference substance and identifying, from among the plurality of data entities, the data entities based on the reference data entity further comprises: identifying data entities that indicate the particular delivery route of the reference substance in addition to the particular active ingredient of the reference substance [Arends at Para. 61 (see Claim 1 for explanation)].
Regarding Claim 19
Arends/BROUSSARD teach the data processing system of claim 16,
Arends/BROUSSARD further teach wherein: identifying data entities that indicate the particular active ingredient of the reference substance comprises identifying, in memory of the data processing EHR system, a set of data entities mapped to the reference data entity [Arends at Para. 61 (see Claim 1 for explanation)].
Regarding Claim 20
Arend teaches a non-transitory computer-readable medium storing instructions that, when executed by a computer hardware processor, cause the computer hardware processor to perform a method for automatically substituting information into orders generated in an electronic health record (EHR) system prior to persisting the orders being persisted in storage of the EHR system, the method comprising:
storing, in the storage of the EHR system [Arends at Para. 0039 (see Claim 1 for explanation)]:
a plurality of data entities that each store data for a particular substance [Arends at Para. 0087 (see Claim 1 for explanation)];
and a plurality of substitution groups each assigned a subset of the plurality of data entities and including a substitution configuration, the plurality of substitution groups including a first substitution group, the first substitution group [Arends at Para. 0061 (see Claim 1 for explanation)]:
assigned a first subset of data entities sharing a common active ingredient of respective substances, the first subset of data entities including a first data entity storing data for a first substance and a second data entity storing data for a second substance [Arends at Para. 0061 (see Claim 1 for explanation)];
and including a first substitution configuration indicating a first instruction for the first data entity, wherein execution of the first instruction replaces the first data entity with the second data entity in a generated order template [Arends at Para. 0114 (see Claim 1 for explanation)];
and generating a first order template in response to input requesting generation of a first order for the first substance in the EHR system, the first order template indicating a first data entity of a first subset of data entities assigned to a first substitution group of a plurality of substitution groups, the first subset of data entities sharing a common active ingredient of respective substances, wherein [Arends at Para. 0034 (see Claim 1 for explanation)]:
the first subset of data entities includes the first data entity storing information for a first substance and a second data entity storing data for a second substance [Arends at Para. 0061 (see Claim 1 for explanation)];
and the first substitution group includes a first substitution configuration indicating a first instruction for the first data entity, wherein execution of the first instruction replaces the first data entity with the second data entity in a generated order template [Arends at Para. 0114 (see Claim 1 for explanation)];
determining that the first data entity is assigned to the first substitution group in the memory [Arends at Para. 0034 (see Claim 1 for explanation)];
modifying the first order template based on the first data entity substitution configuration at least in part by replacing the first data entity indicated by the first order template with the second data entity to obtain a modified first order template [Arends at Para. 0061 (see Claim 1 for explanation)];
Arends does not teach in response to determining that the first data entity is assigned to the first substitution group in the memory, execute the first instruction for the first data entity prior to the persistence of the first order in the HER system, the execution comprising:
and persisting, in the EHR system, the first order by storing information, in the first order, from the second data entity indicated by the modified first order template instead of information from the first data entity such that the second substance is substituted in place of the first substance in the first order.
BROUSSARD teaches in response to determining that the first data entity is assigned to the first substitution group in the memory, execute the first instruction for the first data entity [BROUSSARD at Para. 0079 (see Claim 1 for explanation)] prior to the persistence of the first order in the HER system, the execution comprising [BROUSSARD at Para. 0075 (see Claim 1 for explanation)]:
and persisting, in the EHR system, the first order by storing information, in the first order, from the second data entity indicated by the modified first order template instead of information from the first data entity such that the second substance is substituted in place of the first substance in the first order [BROUSSARD at Para. 0047 (see Claim 1 for explanation)].
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made to combine the noted features of the healthcare data with teaching of BROUSSARD since the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the transaction data of the BROUSSARD for the healthcare records of Arends. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine data of Arends with the prior to persistence of BROUSSARD with the motivation to improve the level of customer service by proactively counseling the customer 32 [BROUSSARD at Para. 66].
Claims 4, 18 rejected under 35 U.S.C. 103(a) as being unpatentable over Arends, BROUSSARD as applied to claim 1, 15, 20 above, and further in view of PIRANI et al (Foreign Publication WO-2024026150-A1).
Regarding Claim 4
Arends/BROUSSARD teach the data processing system of claim 2,
Arends/BROUSSARD further teach wherein assigning at least some of the identified data entities to the first substitution group comprises:
presenting, in a graphical user interface (GUI), the identified data entities [Arends at Para. 44 teaches the central processing system 140 implements a server application 113 for providing data to a user interface application 111 operating on the workstations 128];
and assigning the at least some data entities to the first substitution group in response to receiving the user input through the GUI [Arends at Para. 113 teaches the patient message may indicate that the medication included within the electronic prescription data has been replaced with the alternate medication.].
Arends/BROUSSARD do not teach receiving, through the GUI, user input selecting the at least some data entities;
PIRANI teaches receiving, through the GUI, user input selecting the at least some data entities [PIRANI at Para. 0034 teaches Figure 5 illustrates an interface of the System App showing a system Digital Wallet in an embodiment. This interface includes a region 501 for a first user “Adam Apple” and a region 502 for a second user “Annie Apple.” For each user their medications are listed with date of most recent transaction included. Selecting one of the medications results in the interface of Figure 6, illustrating prescription history and details of that medication. Region 601 shows the user and the name of the medication. Region 602 provides a history of each prescription filled, the date, and quantity prescribed, as well as the status for each entry];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Arends, BROUSSARD with the input selection of PIRANI with the motivation to improve the ability to apply Al and machine learning to the prescription and the fulfilment process.
Regarding Claim 18
Arends/BROUSSARD teach the data processing system of claim 16,
Arends/BROUSSARD further teach wherein assigning at least some of the identified data entities to the first substitution group comprises:
presenting, in a graphical user interface (GUI), the identified data entities [Arends at Para. 44 (see Claim 4 for explanation)];
and assigning the at least some data entities to the first substitution group in response to receiving the user input through the GUI [Arends at Para. 113 (see Claim 4 for explanation)].
Arends/BROUSSARD do not teach receiving, through the GUI, user input selecting the at least some data entities;
PIRANI teaches receiving, through the GUI, user input selecting the at least some data entities [PIRANI at Para. 0034 (see Claim 4 for explanation)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Arends, BROUSSARD with the input selection of PIRANI with the motivation to improve the ability to apply Al and machine learning to the prescription and the fulfilment process.
Response to Arguments
Claim Objections
Regarding the objection(s) to Claims 11111-111112, the Applicant has amended the claims to overcome the basis/bases of objection.
Drawings
Regarding the drawing objection(s), the Applicant has submitted replacement drawings which have alleviated several drawing issues; however, additional issues remain. As such, the objection is maintained.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-20, the Examiner has considered the Applicant’s arguments; however the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
At least the limitations emphasized above do not recite any abstract idea. The above emphasized steps recite specific data structures stored in memory and data operations performed in storage of an EHR system, and not a method of organizing human activity or any other grouping of abstract ideas.
The Specification describes technology that allows substitutions to be implemented in orders generated in an EHR system before the orders are persisted in storage of the EHR system. The techniques eliminate post order persistence data updates in storage of the EHR system and processing involved in these data updates. The techniques perform substitution in real-time while an order is being generated to perform substitution before persistence in the storage of the EHR system. The technology introduces new data structures in storage of the EHR system that enable preorder persistence substitutions. The new data structures are called "substitution groups" that are a group of data entities storing data for substances that share an active ingredient (see, e.g., Present Application, p. 7 ln. 18 -p. 8 ln. 27). A substitution group further includes a substitution configuration that stores instruction(s) for substituting one data entity of a substitution group in place of another in order templates from which orders are generated and persisted (Present Application, p. 14 ln. 28 - p. 15 ln. 8). When a new order is generated in an EHR system in response to input, the processing system can evaluate the substitution configuration for any instructions for substituting a particular drug indicated in the order (Id.). By employing the substitution groups and the substitution configuration data structures, the claimed technology enables the substitution to be performed prior to persistence of the order in memory. Namely, the system can efficiently determine potential substitution group(s) for an order based on the shared active ingredient of the substitution groups. The associated substitution configuration then provides various instructions so that the substitution in the order can be performed efficiently among the different entities in the substitution groups.
The claims of the present application, when viewed as a whole, recite the improvement over conventional data processing systems described in the specification and discussed during the interview. As explained in the discussion of the specification above and further during the interview, the above-cited limitations of independent claim 1 provides an improvement over
conventional EHR technology by enabling accurate order substitution prior to the persistence of the order in memory. This eliminates the problem of incorrect orders being persisted (e.g., in patient records) and eliminates data update operations that conventional EHR systems have to perform.
Regarding (a), the Examiner respectfully disagrees. The steps of assigning, generating, determining, executing and modifying represent rules or instructions for a human to follow.
Regarding (b-c), the Examiner respectfully disagrees. It is unclear to one skilled in the art how performing these functions prior to persisting the order improves the technological environment to which the claims are confined (a computer). The same steps are still being performed to conventional systems but in a different order. It is unclear how the accuracy is improved by changing the order. Any improvements represent improvements to the abstractions, which cannot provide a practical application or significantly more.
Rejection under 35 U.S.C. § 103
Regarding the rejection of Claims 1-20, the Examiner has considered the Applicant’s arguments; however the arguments are not persuasive. Applicant argues:
Arends does not utilize any substitution group assigned data entities that store data for substances, or a substitution configuration of such a substitution group as claimed. Moreover, Arends does not describe any mechanism for substituting drugs into a pharmaceutical group prior to persistence of the pharmaceutical record. Thus, Arends fails to describe "memory storing ... a plurality of substitution groups each assigned a subset of the plurality of data entities and including a substitution configuration," "determining that the first data entity is assigned to the first substitution group in memory," or "in response to determining that the first data entity is assigned to the first substitution group, execut[ing] the first instruction for the first data entity prior to the persistence of the first order in the EHR system," as recited in independent claim 1.
Broussard similarly describes a drug order processing system that can perform drug substitution processes (Broussard, Abstract). However, the drug substitution performed in Broussard does not involve any substitution group assigned data entities storing data for substances, or a substitution group. Broussard also fails to provide a mechanism for performing substitution in a drug order prior to the drug order being persisted in an EHR.
Regarding (a), the Examiner respectfully disagrees. While the prior art of Arends does not explicitly disclose the steps happening prior to persistence, the combination of the healthcare records with the prior art of BROUSSARD at Para. 0075 teaches the steps happening prior to persistence. The Examiner respectfully points to the 103 Rejection of this Office Action for full explanation.
Regarding (b), while not agreeing to the statement, the Examiner did not specifically recite BROUSSARD as teaching those limitations.
Conclusion
The prior art made of record and not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
FOTSCH et al (US Publication No. 20230197222) discloses methods and apparatuses for changing a prescribed medication for a patient.
Koneru et al (US Publication No. 7765110) discloses a system and methods are provided for delivering to a patient a substitute medical therapy with restricted distribution or access.
JANG et al (Foreign Publication KR-20230023156-A) discloses a method and system for recommending alternative medicines.
THIS ACTION IS MADE FINAL, as necessitated by amendment. 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 extension fee 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 JONATHAN C EDOUARD whose telephone number is (571)270-0107. The examiner can normally be reached M-F 730 - 430.
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/JONATHAN C EDOUARD/Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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