DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to the application filed on 11/19/24.
Claims 1-2 are currently pending and have been examined.
Foreign Priority
Acknowledgment is made of Applicant's claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of parent application no. JP2022130329, filed in Japan on 08/18/2022, was received on 11/19/24. Acknowledgement is made of this application’s status as a 371 national stage application of PCT/JP2023/029385, filed on 08/12/23. Accordingly, a priority date of 08/18/2022 has been given to the instant application.
IDS
The information disclosure statement (IDS) submitted on 11/19/24 has been considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Notice to Applicant
The claims appear to be a translation from a foreign language. Examiner has included her interpretation of ambiguous language with the relevant claim mappings in 103 section, and has examined the instant application as best understood. Examiner strongly recommends reviewing and amending the claim language to clarify the scope of the invention and what is actually being claimed.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “means for downloading elements of an electronic health record system” in claim 1. Applicant’s specification para. [0032] discloses “An electronic health record system according to the present invention includes a server device, a database, and a terminal”; where para. [0033] discloses “The server device is a known computer device” and para. [0051] discloses “The terminals are a group of devices such as PCs, tablets, and smartphones”. Therefore, this limitation of a “means for downloading elements” of an EHR system is being interpreted as a general purpose computing device.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) 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(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “support software (support modules)” in line 2 which renders the metes and bounds of the claim indefinite. It unclear what exactly is being claimed, e.g., whether it is support software or support modules. Parenthesis should be used for reference numbers to the drawings and acronyms in claims. For purposes of examination, it is being interpreted as support software.
Claim 1 recites “medical/nursing care facility” at lines 17 and 19 which renders the metes and bounds of the claim indefinite. It is unclear if this refers to a medical care facility or a nursing care facility, or a facility providing both medical and nursing care. For purposes of examination, it is being interpreted as any facility that provides medical care or nursing care.
Claim 2 is rejected as it inherits the deficiencies of parent claim 1.
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 1-2 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1-2 are drawn to a system, which is within the four statutory categories. Claims 1-2 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recites implementing the steps of:
creating of documents for each of a plurality of different occupations in medical and nursing care and enabling documents created by different occupations to be referenced between any combination of occupations,
recording any number of respective definitions of the different occupations, the documents created by the different occupations, data relating to sections being input areas used in the documents, and description items used in the documents, which are elements of the health record system,
receiving elements of a health record system necessary for a medical/nursing care facility (“elements” are interpreted as being “description items, sections, and document categories constituting a health record” per Applicant’s specification [0054]), and
configuring a health record of a medical/nursing care facility based on elements of a health record system that are necessary for the medical/nursing care facility.
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Creating documents for each of a plurality of different occupations within the healthcare field by recording respective definitions, documents created, data related to sections of documents and description items used in the documents; receiving elements of a health record system necessary for a medical/nursing care facility, and subsequently configuring a health record of the medical/nursing care facility using those elements, are personal behaviors that may be performed by personnel working in the healthcare field.
Claim 1 is therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
an electronic health record system including a combination of support software (support modules) by occupation as implementing the steps of supporting creation of documents for each of a plurality of occupations in medical and nursing care and enabling documents created by the occupations to be referenced between any combination of occupations
an electronic health record element database as implementing the steps of recording any number of respective definitions of the support modules, the documents created by the support modules, data relating to sections being input areas used in the documents, and description items used in the documents, which are elements of the electronic health record system
means for downloading elements of an electronic health record system necessary for a medical/nursing care facility as implementing the step of obtaining health record elements (“elements” are interpreted as being “description items, sections, and document categories constituting a health record per Applicant’s specification [0054])
The broad recitation of the above-mentioned general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools.
Regarding the “electronic health record system”, recitation of an “electronic” system only amounts to applying a health record system using computers; Para. [0032] discloses “An electronic health record system according to the present invention includes a server device, a database, and a terminal”; where para. [0033] discloses “The server device is a known computer device, and includes an arithmetic device, a main storage device, an auxiliary storage device, an input device, an output device, and a communication device”; para. [0045] discloses “The database stores information handled by the electronic health record system”; and para. [0051] discloses “The terminals are a group of devices such as PCs, tablets, and smartphones”. All of these components (server device, database, and terminal) are understood to be general purpose computing elements functioning in their ordinary capacities to apply the abstract idea.
Regarding the “database”, no structure or particulars appear to be provided. Para. [0045] discloses “The database stores information handled by the electronic health record system” and para. [0054] discloses “database, which is also on the cloud, registers/manages elements, such as description items, sections, and document categories”. The database is understood to amount to an electronic means of storing/managing data, and as such, it amounts to mere instructions to apply the abstract idea on a computer.
Regarding “support software”/”support modules”, per para. [0016], [0017] and [0020], this is understood to be software modularized for different occupations (e.g., nurse software vs. doctor software) used in an EHR workflow. No particulars of the modules are provided, and as such, it amounts to mere instructions to apply the abstract idea on a computer.
Regarding a “means” for “downloading”, para. [0043] discloses “The system of the present application includes a means (program) for downloading elements of an electronic health record system necessary for a medical/nursing care facility and for configuring an electronic health record of the medical/nursing care facility”. As discussed in 112(f) section above, this is understood to be a program running on a general purpose computing device (e.g., server/terminal functioning in its ordinary capacity, see paras. [0033]/[0051]) which only amounts to mere instructions to apply the abstract idea; “downloading” data only amounts to mere instructions to apply the abstract idea, e.g., using a computer functioning in its ordinary capacity to electronically receive data.
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claim 1 only recites the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Depending Claim
Dependent claim 2 recites “wherein the electronic health record system enables an electronic health record element corrected or newly created in a medical/nursing care facility to be registered in the electronic health record element database”, which comprises an additional element in the form of insignificant extra-solution activity. As explained above, Claim 1, from which Claim 2 depends, is directed to an abstract idea in the form of configuring a medical record for a medical/nursing facility specific to the medical/nursing facility’s needs. As stated in MPEP 2106.05(g), "[t]he term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim." In the present claim, the function of “registering”, interpreted as “storing”, a corrected or newly created health record element in a database is only nominally or tangentially related to the process of configuring a medical record that is specific to a medical/nursing facility’s needs, and accordingly constitutes insignificant extra-solution activity.
In addition to amounting to insignificant extra-solution activity, the above limitations also
constitutes well-understood, routine and conventional activity in the form of storing/retrieving information in memory. These types of activities have been recognized by the courts as well-understood, routine and conventional activity when claimed as insignificant extra-solution activity. See MPEP 2106.05(d).
Dependent claim 2, when analyzed as a whole, is held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. This claim fails to remedy the deficiencies of its parent claim above, and is therefore rejected for at least the same rationale as applied to the parent claim above, and incorporated herein.
For the reasons stated, Claims 1-2 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Higbie et. al. (US Publication 20120109686A1) in view of Reicher et. al. (US Publication 20170039350A1)
An electronic health record system ([0004], an electronic medical record system) including a combination of support software (support modules)([0099] teaches on the EMR system including a workstation (computer/tablet) and “method software package” which is interpreted as “support software”/”support modules”) that supports creation of documents for each of a plurality of ([0034] teaches on customizing templates for inputting patient information so that entirely new categories can be added; the EMR system permits the user to create new templates; [0034] teaches on a template builder which allows a provider to “add vitals pertinent to the practice”, e.g., number of toes or teeth; the example of customizing a template to add additional tests related to a “skin exam” – enabling a user to customize a template so that it can be tailored to include patient information “pertinent to the practice” – e.g., related to teeth, toes or skin is interpreted as creating documents for a ‘plurality of practices in medical and nursing care’), the electronic health record system enabling documents created by the support modules to be referenced between any combination of the support modules ([0090]-[0097] teach on using the EHR system; step (d) with respect to creating a new customizable template, includes “setting template properties including providing a name for the template and linking the template with other templates” – Examiner interprets “linking the template with other templates” to read on “enabling documents created by the support modules (software) to be referenced between any combination of the support modules (software)” as the software; [0098] teaches on once a template has been created, the information it contains can be searched along with the information in standard templates – also interpreted as the EHR system “referencing” documents created by the support modules, where [0063] teaches on patient data being able to be measured against data from physicians or “other users” of the system – interpreted as occupations associated with support modules (software) using the system), the electronic health record system comprising:
an electronic health record element [storage] (paras. [0222]-[0234] teach on a user accessing the Practice Manager, which gives access to “template editor”; the user can select “template/queries” and “open the desired template for editing, select which common items make up the template” (DD/EE at [0223]-[0224]); subordinate templates may be added (II at [0228]), the user can create a new template from among several categories such as welcome, problem review, family history, health screen, labs/orders, procedures, allergies, social history, etc. (KK at [0230]) – Examiner interprets all of the different sections/common items to read on EHR “elements”; if the user “opens a template for editing” and can add items/sections, it is interpreted as an EHR element “storage” as the system enables the user to retrieve existing templates for editing as well as create new templates from existing categories/sections) configured to record any number of respective definitions of the support modules ([0090]-[0097] teach on using the EHR system; step (d) with respect to creating a new customizable template, includes “setting template properties including providing a name for the template and linking the template with other templates; defining a template panel by providing a name for the template panel and a number of columns for the template; and defining fields or line items in the template and defining the type of data in the fields or items – interpreted as “recording respective definitions” of the support modules, e.g., the software used for creating the templates), the documents created by the support modules ([0225] teaches on a user accessing the EMR system and selecting templates/queries on the left which enables the user to edit, delete, or create a template; the user can select a panel title to add an item to the panel or edit the panel of a currently opened template – interpreted as teaching that documents (templates) previously created by the support modules (software) have been recorded in the EHR database as they can be selected and subsequently used/modified/deleted), data relating to sections being input areas used in the documents ([0034] teaches on a template builder, in which a practitioner can add vitals pertinent to the practice, e.g., height, weight temperature, pulse, number of toes/teeth; for example, for a skin exam, user can customize a template to add additional test common to the practice/market; for example, for a template on “social history” (social history is the “section being input”), user can select items to enter, e.g., exercise, work, living arrangement (data related to the section of social history); similarly [0226] teaches on editing/creating an available template including a drop down menu for available data types), and description items used in the documents ([0299]-[0300] teach on use of patient name to locate saved records; see Fig. 15A showing name “Abraham Lincoln” and birthdate shown at top of medical record; patient name and birthdate are interpreted to be “description items” per Applicant’s specification para. [0067]/Fig. 3), which are elements of the electronic health record system (the previous citations, e.g., [0299]-[0300], [0034] teach on description items, data relating to sections being input as “elements” of the EHR system); and
a means for downloading elements of an electronic health record system necessary for a medical/nursing care facility ([0099] teaches on the client or user, typically a healthcare professional such as a doctor and/or his/her staff, receiving the Provider and Support Company, materials for enabling use of the system including workstations (computer and/or tablet) and the method software package; [0103] teaches on a user accessing the EMR manager and downloading software updates; Examiner interprets downloading software updates using a workstation computer (“means”) to read on “downloading elements” of the EHR system necessary for a care facility) and for configuring an electronic health record of the medical/nursing care facility ([0254]-[0256] teach on a user logging into the system via EMR Launch window, interpreted as occurring from the workstation (“means”), and accessing the EMR manager to customize system settings, screen appearances, templates, queries and data entry shortcuts – interpreted as “configuring” an EHR if the user is customizing “templates”; where [0222]-[0232] teach on various aspects of configuring a template, e.g., [0230] discloses “Create a new template from among several categories (Welcome, Problem Review, Family History, Health Screen, Labs/Orders, Procedures, Allergies, Immunizations, Social History, History/ASS/ROS, Physical Exam, Assessment, and Plan)’).
Higbie does not explicitly disclose, but Reicher, which is directed to a system and method of providing dynamic and customizable medical examination forms, teaches:
database ([0033] teaches on a dynamic examination form template database which stores created examination form templates that have been created by the dynamic examination form software)
a combination of support software (support modules) by occupation that supports creation of documents for each of a plurality of occupations in medical and nursing care
([0047] teaches on selecting a dynamic examination template based on specified criteria which may include attributes related to the user of the form including general attributes such as specialty or user role (synonymous with “occupation”); [0099]-[0100] further teach on a user interface for medical examination forms to be set up, created, copied, saved, modified and designed; tabs displayed and user interface may be dependent on the user’s role, e.g., a clerical employee may not have permission to use certain functionality/forms in the system whereas a medical doctor could have extensive permission and be able to view tabs not presented to other users – the functions are interpreted as being employed by support software/support modules “by occupation” if they enable different user types to have different permissions, e.g., the clerical employee and the medical doctor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Higbie with these teachings of Reicher, to implement the electronic health record element system as a database, with the motivation of storing templates in a way that they can be accessed remotely via the internet (Reicher [0033]) and to utilize software supporting creation of documents for each of a plurality of occupations in medical care, with the motivation of allowing multiple users having different roles in the clinical process to collaborate and contribute to a medical examination report (Reicher [0023]).
Regarding Claim 2, Higbie/Reicher teach the limitations of Claim 1. Higbie further discloses wherein the electronic health record system enables an electronic health record element corrected or newly created in a medical/nursing care facility to be registered in the electronic health record element database ([0222]-[0232] teaches on using the template editor to select common items to make up the template – different practices see patients with different issues so items can easily be added or removed from the list; selecting Templates/Queries enables the user to edit or create new templates; after a template has been edited or used as a basis for creating a new template, user selects “Save As” to save the new template – interpreted as “registering” a newly created or edited (“corrected”) document in the EHR element database of Higbie/Reicher).
Conclusion
Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20170300634A1, teaching on a customizable hardware and software architecture for managing electronic healthcare information which can be customized to fit the needs of the user
US Publication 20130173602 A1, teaching systems and methods for formlet generation and presentation
US Publication 20140047327 A1, teaching on document creation and management systems and methods using a template editor to enable a user to add categories/sub categories to specify input to be gathered to generate a document
US Publication 20140214451A1, teaching on an adaptive medical documentation system which accesses a knowledge database to provide information for generating a document based on situation elements of a context
US Publication 20220084664A1, teaching on a system for dynamic health records using custom templates
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE-MARIE K ALDERSON whose telephone number is (571)272-3370. The examiner can normally be reached on Mon-Fri 9:00am-5:00pm EST and generally schedules interviews in the timeframe of 2:00-5:00pm EST.
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682