DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed March 17, 2026.
Claims 1-7 are pending.
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(s)
Claims 1-7 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 1-7 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter based on the grounds set out in detail below:
Independent Claims 1 and 7:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Independent claims 1 falls within the statutory category of machine.
Independent claim 7 falls within the statutory category of method.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claims 1 and 7 (claim 1 being representative) claimed invention is directed to an abstract idea without significantly more.
The claim elements which set forth the abstract idea in the independent claims (claim 1 being representative) is:
accessing and maintaining patient medical records, and in which such records are remotely accessible by participating patients and participating doctors,
storing first doctor's patient medical records (531, 532) relating to the first doctor's patients;
storing second doctor's patient medical records (631, 633) relating to the second doctor's patients;
arranged to allow communication
based on a first patient trusted doctor file (230)
for the first patient that each identify a location of the corresponding first patient medical records (531, 631)
subject to the first doctor and second doctor being identified as a trusted doctor in a first patient trusted doctor file (230), to allow to obtain and store links (251, 261) for assessing first patient medical records (531, 631) associated with the first patient,
and to allow to access the first patient medical records (531, 631) associated with the first patient through the stored links (251, 261).
This abstract idea is “certain methods of organizing human activity” as it is following rules and instructions to access patient medical records (MPEP § 2106.04(a)(2), subsection II)
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent claims 1 and 7 judicial exception is not integrated into a practical application.
In Claim 1 the additional elements are:
A medical record system comprising a server and a two-way firewall
a first patient access computer device
a first patient database stored on or associated with the first patient access computer device
a first doctor access computer device
a first doctor database
a second doctor access computer device
a second doctor database
a cloud network
the access devices
the connected devices
databases
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional element (a) is executing the abstract idea and recited as tools or equivalent to apply the abstract idea as “apply-it” to gather, manipulate, and output data
The additional elements, (b), (c), (d), (e), (f), (g), (h), (i), (j), (k), are listed above are performing the abstract idea and stated as tools or equivalent to apply the abstract idea as “apply-it” to gather and store data
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claims do not include additional elements sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2 above, these additional elements, whether viewed individually or as an ordered combination, amount to no more than applying the abstract idea thus insufficient to provide “significantly more”. Therefore, the claim does not amount to significantly more and the claim is ineligible.
Dependent Claims 2-6:
Eligibility Step 1 (does the subject matter fall within a statutory category?):The dependent claims 2-6 fall within the statutory category of machine.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2-6 claimed invention is directed to an abstract idea without significantly more. The claims continue to limit the independent claim 1 abstract idea by (1) further limiting the types of data and (2) further the rules and instructions to access medical records. Therefore, the dependent claims inherit the same abstract idea which is “certain methods of organizing human activity” as it is following rules and instructions to access patient medical records (MPEP § 2106.04(a)(2), subsection II)
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For claims 2-6 this judicial exception is not integrated into a practical application.
The dependent claims recite no additional elements not already recited in the independent claims thus are purely considered the abstract idea.
Accordingly, the dependent claims as a whole do not integrate the recited abstract idea into a practical application (MPEP 2106.05(f) and 2106.04(d)(1).
Eligibility Step 2B (Does the claim amount to significantly more?): The dependent claims do not include additional elements not already recited in the independent claims therefore are purely considered the abstract idea and do not provide significantly more. The claims are patent ineligible.
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.
Claims 1, 3, 4, 5, 6, and 7 are rejected to under 35 U.S.C. 103 as being unpatentable over Shelton (US20150331999A1) in view of Callahan et. al (hereinafter Callahan) (US20020157023A1)
As per claim 1, Shelton teaches:
A medical record system (10) for accessing and maintaining patient medical records, and in which such records are remotely accessible by participating patients and participating doctors, the system comprising a server (100); (see Fig. 1 and see [0090] discloses, “While the instant invention is applicable broadly to systems and methods of searching databases requiring prior approval for confidential access, it will be described with respect to medical records data bases accessible over the Internet where access requires approval by one or more third parties, such as a patient. It will be evident that a local area network (LAN), intranet or wide area network (WAN) can also be utilized.” And see [0091] discloses, “Referring to the drawings, FIG. 1 depicts the principal components of a preferred system in accordance with the principles of the invention. Shown as 10a 10c are clients, i.e., healthcare information users requiring access to medical records and patients for whom such records are held. Such healthcare information users can be hospitals, doctors, nursing services, nursing homes, insurance companies, patients, druggists, employers, and the like. For ease of illustration the invention will be further described with the healthcare information user being a doctor.”)
a first patient access computer device (200) ([0091] discloses, “Referring to the drawings, FIG. 1 depicts the principal components of a preferred system in accordance with the principles of the invention. Shown as 10a 10c are clients, i.e., healthcare information users requiring access to medical records and patients for whom such records are held. Such healthcare information users can be hospitals, doctors, nursing services, nursing homes, insurance companies, patients, druggists, employers, and the like. For ease of illustration the invention will be further described with the healthcare information user being a doctor.” And see [0092] discloses, “Before describing the system and method in detail and referring to the drawings, it will be evident that the client, i.e., the doctor, will need to have an adequate conventional computer terminal and printer and that the terminal be connected as by telephone 31, 32, or 33, or satellite or other means to the Web by means of any conventional Internet service provider.” / examiner notes computer terminal is considered a computer device)
and a first patient database (210) stored on or associated with the first patient access computer device (200); ([0019] discloses, “Briefly, the present invention comprises a medical database Supervisory control system comprising: (a) at least one database including medical data individually relating to each of a plurality of patients” and see [0091] discloses, “Referring to the drawings, FIG. 1 depicts the principal components of a preferred system in accordance with the principles of the invention. Shown as 10a 10c are clients, i.e., healthcare information users requiring access to medical records and patients for whom such records are held. Such healthcare information users can be hospitals, doctors, nursing services, nursing homes, insurance companies, patients, druggists, employers, and the like. For ease of illustration the invention will be further described with the healthcare information user being a doctor.” And see [0092] discloses, “Before describing the system and method in detail and referring to the drawings, it will be evident that the client, i.e., the doctor, will need to have an adequate conventional computer terminal and printer and that the terminal be connected as by telephone 31, 32, or 33, or satellite or other means to the Web by means of any conventional Internet service provider.” / examiner notes computer terminal is considered a computer device and notes “associated with” is given BRI therefore that the disclosure teaches that the terminal devices for users where the user can be a patient and that the database is a patient database therefore both associated with patients)
a first doctor access computer device (500) ([0091] discloses, “Referring to the drawings, FIG. 1 depicts the principal components of a preferred system in accordance with the principles of the invention. Shown as 10a- 10c are clients, i.e., healthcare information users requiring access to medical records and patients for whom such records are held. Such healthcare information users can be hospitals, doctors, nursing services, nursing homes, insurance companies, patients, druggists, employers, and the like. For ease of illustration the invention will be further described with the healthcare information user being a doctor.” And see [0092] discloses, “Before describing the system and method in detail and referring to the drawings, it will be evident that the client, i.e., the doctor, will need to have an adequate conventional computer terminal and printer and that the terminal be connected as by telephone 31, 32, or 33, or satellite or other means to the Web by means of any conventional Internet service provider.” / examiner notes computer terminal is considered a computer device)
and a first doctor database (510) for storing first doctor's patient medical records (531, 532) relating to the first doctor's patients;([0067] discloses, “Another object of the invention is to provide a means by which the traditional information flow (from a centralized database, hospital or lab TO an individual physician) can also function in reverse, depending on the types of information requested, and to thereby permit patient records held by independent doctors offices and clinics to be as accessible as data held in a central database warehouse, including any hospital or testing laboratory.” And see [0132] discloses, “Typically on the Internet, a larger computer functions as a server and a smaller computer (for example, a work station) as a client. Something similar is also true in health care where the legacy database systems maintained by hospitals and large testing laboratories are typically the data providers; and the individual physicians offices are most often the data consumers. The system of the present invention takes full advantage of the Internet's distribution capabilities and permits this information flow to also function in reverse, depending on the types of information requested. Although not shown in the drawings, another client could be the repository of the data, in fact, acting within the system as Legacy Data Base 21. This capability is particularly vital in the healthcare industry since much of the patient record is distributed between independent doctors offices and clinics rather than held in a central data warehouse, as in other industries.” / examiner notes that the client computer terminals can be doctor or patient in the disclosed art of record. The legacy database interpreted as a doctor database as it houses patient information from hospital and lab accessible by doctor(s))
a second doctor access computer device (600) (see Fig. 1 10a-10c) and a second doctor database (610) for storing second doctor's patient medical records (631, 633) relating to the second doctor's patients; (see [0095] discloses, “The term “Legacy Data Base” means any existing database Such as a doctor's records or medical records of a hospital, nursing home, and the like.” And see [0094] discloses, “In short, the instant system and method utilize existing computer hardware and existing communication links, Such as the Internet and intranet, in order to access databases without compromising the vital considerations of privacy of patient information and rigorous control of access, as well as retaining records of the access requester.” And see [0129] discloses, “In its preferred foiiii, the instant invention is designed with three primary “stakeholders” in mind: the physician, the IS/IT administrator and the patient. Unlike any other medical search engines, the instant invention takes full advantage of the Internet to access institutional databases while taking into consideration the competing requirements of rapid access to patient records and medical information, security, privacy and economics.” see also [0130] and [0141]-[0142]) / examiner notes under BRI someone of ordinary skill in the art would understand the disclosure of record teaches pulling information from various institutional databases therefore plural and being atleast two or more therefore having a first and second databases where patient information is housed and accessed.”)
and a cloud network (800), (see abstract and see [0090] discloses, “While the instant invention is applicable broadly to systems and methods of searching databases requiring prior approval for confidential access, it will be described with respect to medical records data bases accessible over the Internet where access requires approval by one or more third parties, such as a patient. It will be evident that a local area network (LAN), intranet or wide area network (WAN) can also be utilized. / examiner notes instant application spec. Page 6 lines 13-16 recites “These access devices may also be computers or mobile devices running appropriate software for connecting to the system through the cloud network, such as the internet.” Thus examiner sites to an example cloud network such as internet or intranet from prior art disclosure)
over which the access devices (200, 300, 400, 500,600, 700) and databases (210, 310, 410, 510, 610, 710) are connected to the server, arranged to allow communication between the connected devices (200,500, 600) and databases (210, 510, 610); stored in the first patient database (210)…[…]… stored in the first doctor database (510) and in the second doctor database (610) (see Fig. 1 and see [0094] discloses, “In short, the instant system and method utilize existing computer hardware and existing communication links, Such as the Internet and intranet, in order to access databases without compromising the vital considerations of privacy of patient information and rigorous control of access, as well as retaining records of the access requester.” And see [0100] discloses, “After entry is approved and the order submitted, the search engine, Server 12, will produce a prioritized index from Master Index 13 of all documents meeting the specified criteria, together with a hypertext link or similar connection to an order form for securing a copy. The search results will report the approximate number of documents found that match the search criteria; the title and type of each such document; and the date it was created, name of the ordering physician and location (or locations) where these records are held.” And see [0095] discloses, “The term “Legacy Data Base” means any existing database Such as a doctor's records or medical records of a hospital, nursing home, and the like.” And see [0094] discloses, “In short, the instant system and method utilize existing computer hardware and existing communication links, Such as the Internet and intranet, in order to access databases without compromising the vital considerations of privacy of patient information and rigorous control of access, as well as retaining records of the access requester.” And see [0129] discloses, “In its preferred foiiii, the instant invention is designed with three primary “stakeholders” in mind: the physician, the IS/IT administrator and the patient. Unlike any other medical search engines, the instant invention takes full advantage of the Internet to access institutional databases while taking into consideration the competing requirements of rapid access to patient records and medical information, security, privacy and economics.” see also [0130], [0132] and [0141]-[0142] and see [0067] and see ([0019] discloses, “Briefly, the present invention comprises a medical database Supervisory control system comprising: (a) at least one database including medical data individually relating to each of a plurality of patients” and see [0091] discloses, “Referring to the drawings, FIG. 1 depicts the principal components of a preferred system in accordance with the principles of the invention. Shown as 10a 10c are clients, i.e., healthcare information users requiring access to medical records and patients for whom such records are held. Such healthcare information users can be hospitals, doctors, nursing services, nursing homes, insurance companies, patients, druggists, employers, and the like. For ease of illustration the invention will be further described with the healthcare information user being a doctor.” And see [0092] discloses, “Before describing the system and method in detail and referring to the drawings, it will be evident that the client, i.e., the doctor, will need to have an adequate conventional computer terminal and printer and that the terminal be connected as by telephone 31, 32, or 33, or satellite or other means to the Web by means of any conventional Internet service provider.” / examiner notes computer terminal is considered a computer device and notes “associated with” is given BRI therefore that the disclosure teaches that the terminal devices for users where the user can be a patient and that the database is a patient database therefore both associated with patients))
However, Shelton does not teach:
wherein the server (100) comprises a two-way firewall (110) arranged based on a
first patient trusted doctor file (230) …[…]…and, subject to the first doctor and second doctor being identified as a trusted doctor in a first patient trusted doctor file (230), to allow the first patient access computer device (200) to obtain and store links (251, 261) for the first patient that each identify a location of the corresponding first patient medical records (531, 631) …[…]…for assessing first patient medical records (531, 631) associated with the first patient, and to allow the first doctor access computer device (500) to access the first patient medical records (531, 631) associated with the first patient through the stored links (251, 261).
However, Callahan teaches:
wherein the server (100) comprises a two-way firewall (110) (abstract discloses, “A System for processing data requests from clients via a network is disclosed. The System has an application Server coupled to a network, and a Semantic firewall to pass and filter the content between the application Server and the clients. The application Server provides content from a database to the clients via the network, and the Semantic firewall restricts access to a portion of the content for one or more clients.”) arranged based on a first patient trusted doctor file (230) …[…]…and, subject to the first doctor and second doctor being identified as a trusted doctor in a first patient trusted doctor file (230), to allow the first patient access computer device (200) to obtain and store links (251, 261) for the first patient that each identify a location of the corresponding first patient medical records (531, 631) …[…]…for assessing first patient medical records (531, 631) associated with the first patient, and to allow the first doctor access computer device (500) to access the first patient medical records (531, 631) associated with the first patient through the stored links (251, 261). ([0072] discloses, “An example of a raw CLIPS rule, i.e. the textual computer program, used to create the file in FIG. 10 is shown in FIG. 11. The rule mentioned above is expressed as a CLIPS rule in the system and is used to guide the transformation process of the XML content produced by the NAS. A rule consists of conditions on the left-hand-side (LHS) of the "=>” symbol and actions on the right-hand-side (RHS) of the “=>” symbol. XML content is processed into a tuple Space. If all conditions match on the LHS of a rule, the rule “fires”, and the actions on the RHS are performed. For example, lines 1104, 1106, 1108, and 1110 represent patterns within the condition of a rule (called rule6). Each pattern contains fixed content or variables. The elements NAME, POSITION and Physician in line 1106 are fixed, while the term “ename” is a variable. Variables match any fixed content of a corresponding tuple in the tuple Space (such as the tuple “(EMPLOYEES-EMPLOYEE (NAME Fred) (POSITION Physician))” from the XML content Scanned into the System). Some variables can match none, one, or any number of terms in a tuple. For example, the variable Srules in line 1110 matches the list of rules that are currently active. Named variables are bound to their values on the entire LHS of a rule. For example, if line 1104 matches the tuple “(SESSIONS-SESSION (NAME Fred))”, line 1106 must match the tuple “(EMPLOYEES-EM PLOYEE (NAME Fred) (POSITION Physician))” in the tuple Space. If Such a tuple does not exist, the entire rule fails to fire because it does not apply. Thus, the rule in FIG. 11 is interpreted as “for the current logged-in user whose name is ename (line 1104), and who is a Physician (line 1106), and not the patient's assigned physician (“-lename” means “NOT EQUAL to ?ename” in line 1108), and not yet under application of this rule (line 1110) (this rule cannot be applied more than once), set the ACCESS attribute to VIEW (line 1112) in the current patient for the fields PID, FNAME, LNAME, BADDRESS, BCITY, BSTATE, BZIP, BPHONE, and LASTVISIT (line 1114).” Line 1116 creates and stores the definition of rule6 in the rules for patients. Other rules (not shown) mark the ACCESS attribute to “none” or "edit” as their conditions dictate, while still other rules delete XML nodes during the transformation from FIG. 9 to the content in FIG. 10 such as INSURER, INSNUM, DOCTOR, VIS ITTIME, PURPOSE, SEENBY, and DIAGNOSIS.” And see [0081] discloses, “The XML fragment shown in FIG. 17 is passed as input to the Second Stage. The Second Stage applies complex Security rules in order to transform the input by adding, deleting, or changing tags, attributes, nodes, and node con tent. In this example, the Second Stage adds a view attribute to each record to indicate which records should be shown or hidden by the next stage in the pipeline. The Second Stage adds the view attribute to the Status tag of each record based on two rules: Rule 1-All physicians can See the list of patient records, Rule 2-Only the physician of the patient can view a medical test record for that patient.” And see [0082] discloses, “Based on these rules, the second stage produces the XML fragment 1802 shown in FIG. 18 as output. The status element 1804 of the first record 1806, the test result for Smith, can be viewed by the current user, Jones, because (1) Jones is a physician and can view all the records according to Rule 1, and (2) Jones is the physician for Smith in accord with Rule 2. The view attribute of the status element 1808 of the second record 1810, which is the test result for patient Morgan, is marked "false' because even though Jones is a physician, Jones is not the physician for Morgan.”) / examiner notes this is a system claim and much of the languages is instructed as intended use also examiner notes under BRI notes someone of ordinary skill in the art would understand the stored rules and definitions as stored links for trusted access/pathways to the databases)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s teachings with Callahan’s teachings, the motivation being Shelton discloses the use of layers of firewalls to protect patient data (e.g. see [0095] and see [0097]) and teaches the importance of being able to easily transfer medical data but the need protect it with adequate laws (in e.g. [0004]-[0017]), therefore the combination with more in depth protection in Callahan would improve the protection from both external threats and internal misuse, ensuring HIPAA compliance, stopping data leaks, and segmenting Electronic Health Records (EHRs) from less secure areas utilizing understood computer elements that would not render the instant invention inoperable.
As per claim 3, Shelton does not teach:
The medical record system (10) according to claim 1, wherein the two- way firewall (110) is arranged to prohibit the first doctor access device (500) to change second doctor's medical records (631, 633) on second doctor database (610).
However, Callahan does teach:
The medical record system (10) according to claim 1, wherein the two- way firewall (110) is arranged to prohibit the first doctor access device (500) to change second doctor's medical records (631, 633) on second doctor database (610). ([0071] discloses, “A rule used to transform the file in FIG. 9 is shown in FIG. 11. The rule is: a physician who is not the patient's own physician (e.g., another doctor at the hospital) is allowed to view billing address information and edit the follow-up visit date and time. In accordance with this rule, field 906 becomes field 1006, having an additional attribute of access="view”, meaning that the field is viewable by the user who is a physician. Similarly, field 908 becomes field 1008 and is viewable by the user; and field 910 becomes field 1010 having the attribute of being editable by the user. The date of the next follow-up visit is also incremented by approximately one month, taking into account holidays and weekends. The remaining fields in 904 are similarly processed based on the rules.” And see [0081]-[0082] / examiner notes under BRI someone of ordinary skill in the art would understand the rules of either access/view or edit are set as needed therefore the semantic firewall is arranged to prohibit access when needed)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s teachings with Callahan’s teachings for the same reasons given for same claim 1.
As per claim 4, Shelton does not teach:
The medical record system (10) according to claim 1, wherein patient medical records (531, 532, 631, 633, 732, 733) comprise a patient-record part and a physician-record part, and the two-way firewall (110) is arranged to allow the patient's access device (200, 300, 400) access to the patient-record part and arranged to prohibit access to the physician-record part of the medical records associated with the respective patient.
However, Callahan does teach:
The medical record system (10) according to claim 1, wherein patient medical records (531, 532, 631, 633, 732, 733) comprise a patient-record part and a physician-record part, and the two-way firewall (110) is arranged to allow the patient's access device (200, 300, 400) access to the patient-record part and arranged to prohibit access to the physician-record part of the medical records associated with the respective patient. ([0071] discloses, “A rule used to transform the file in FIG. 9 is shown in FIG. 11. The rule is: a physician who is not the patient's own physician (e.g., another doctor at the hospital) is allowed to view billing address information and edit the follow-up visit date and time. In accordance with this rule, field 906 becomes field 1006, having an additional attribute of access="view”, meaning that the field is viewable by the user who is a physician. Similarly, field 908 becomes field 1008 and is viewable by the user; and field 910 becomes field 1010 having the attribute of being editable by the user. The date of the next follow-up visit is also incremented by approximately one month, taking into account holidays and weekends. The remaining fields in 904 are similarly processed based on the rules. 0072 An example of a raw CLIPS rule, i.e. the textual computer program, used to create the file in FIG. 10 is shown in FIG. 11. The rule mentioned above is expressed as a CLIPS rule in the system and is used to guide the transformation process of the XML content produced by the NAS. A rule consists of conditions on the left-hand-side (LHS) of the "=>” symbol and actions on the right-hand-side (RHS) of the “=>” symbol. XML content is processed into a tuple Space. If all conditions match on the LHS of a rule, the rule “fires”, and the actions on the RHS are performed. For example, lines 1104, 1106, 1108, and 1110 represent patterns within the condition of a rule (called rule6). Each pattern contains fixed content or variables. The elements NAME, POSITION and Physician in line 1106 are fixed, while the term “ename” is a variable. Variables match any fixed content of a corresponding tuple in the tuple Space (such as the tuple “(EMPLOYEES-EMPLOYEE (NAME Fred) (POSITION Physician))” from the XML content Scanned into the System). Some variables can match none, one, or any number of terms in a tuple. For example, the variables rules in line 1110 matches the list of rules that are currently active. Named variables are bound to their values on the entire LHS of a rule. For example, if line 1104 matches the tuple “(SESSIONS-SESSION (NAME Fred))”, line 1106 must match the tuple “(EMPLOYEES-EM PLOYEE (NAME Fred) (POSITION Physician))” in the tuple Space. If Such a tuple does not exist, the entire rule fails to fire because it does not apply. Thus, the rule in FIG. 11 is interpreted as “for the current logged-in user whose name is ename (line 1104), and who is a Physician (line 1106), and not the patient's assigned physician (“-lename” means “NOT EQUAL to ?ename” in line 1108), and not yet under application of this rule (line 1110) (this rule cannot be applied more than once), set the ACCESS attribute to VIEW (line 1112) in the current patient for the fields PID, FNAME, LNAME, BADDRESS, BCITY, BSTATE, BZIP, BPHONE, and LASTVISIT (line 1114).” / examiner notes the email and demographic information is considered patient information. Examiner also notes that the firewall contains rules able to allow patients or others access to specific information based on those rules set)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s teachings with Callahan’s teachings for the same reasons given for same claim 1.
As per claim 5, Shelton does not teach:
The medical record system (10) according to claim 4, wherein both the patient-record part and physician-record part of a patient's medical record (531, 532, 631, 633) are accessible to a doctor access device (500, 600, 700), subject to the doctor being identified as trusted in the respective patient's trusted doctor record (230, 330, 430).
However, Callahan does teach:
The medical record system (10) according to claim 4, wherein both the patient-record part and physician-record part of a patient's medical record (531, 532, 631, 633) are accessible to a doctor access device (500, 600, 700), subject to the doctor being identified as trusted in the respective patient's trusted doctor record (230, 330, 430). ([0081] discloses, “The XML fragment shown in FIG. 17 is passed as input to the Second Stage. The Second Stage applies complex Security rules in order to transform the input by adding, deleting, or changing tags, attributes, nodes, and node con tent. In this example, the Second Stage adds a view attribute to each record to indicate which records should be shown or hidden by the next stage in the pipeline. The Second Stage adds the view attribute to the Status tag of each record based on two rules: Rule 1-All physicians can See the list of patient records, Rule 2-Only the physician of the patient can view a medical test record for that patient.” And see [0082] discloses, “Based on these rules, the second stage produces the XML fragment 1802 shown in FIG. 18 as output. The status element 1804 of the first record 1806, the test result for Smith, can be viewed by the current user, Jones, because (1) Jones is a physician and can view all the records according to Rule 1, and (2) Jones is the physician for Smith in accord with Rule 2. The view attribute of the status element 1808 of the second record 1810, which is the test result for patient Morgan, is marked "false' because even though Jones is a physician, Jones is not the physician for Morgan.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s teachings with Callahan’s teachings for the same reasons given for same claim 1.
As per claim 6, Shelton does not teach:
The medical record system (10) according to claim 1, wherein the two-way firewall (110) is arranged as a distributed firewall.
However, Callahan does teach:
The medical record system (10) according to claim 1, wherein the two-way firewall (110) is arranged as a distributed firewall. ([0056] discloses, “The semantic firewall 312 can be built on open, XML-based standards that allow any enterprise to focus on their core busineSS logic and data modeling tasks and allows enterprise managers to Separate information assurance con cerns outside the core busineSS logic. The Semantic firewall allows managers to control the Security aspects in an easily configurable firewall outside the core System. The Semantic firewall application program interface (API) can be config ured with enterprise ServerS Such as, e.g., J2EE, WebLogic, WebSphere, and Enhydra, to pre-proceSS and post-proceSS XML content via a simple API for XML (SAX)-based API.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s teachings with Callahan’s teachings for the same reasons given for same claim 1.
As per claim 7, it is a method claim which repeats the same limitations of claim 1, the corresponding system claim, as a series of process steps as opposed to a collection of elements. Since the collective teaching of Shelton and Callahan as well as the motivation to combine disclose the structural elements that constitute the system of claim 1, it is respectfully submitted that they perform the underlying process steps, as well. As such, the limitations of claim 7 are rejected for the same reasons given above for claim 1.
Claim 2 is rejected to under 35 U.S.C. 103 as being unpatentable over Shelton (US20150331999A1) in view of Callahan et. al (hereinafter Callahan) (US20020157023A1) and in further view of Menschik et. al (hereinafter Menschik) (US20050027995A1)
As per claim 2, Shelton does not teach:
The medical record system (10) according to claim 1, wherein entries on the first patient medical records (531, 631) have a time stamp, and the two- way firewall (110) is arranged to allow the first doctors access computer device (500) to display a patient record screen incorporating a historical overview of the patient's medical status based on the accessed patient's medical records (531, 631).
However, Callahan does teach the underlined portion:
The medical record system (10) according to claim 1, wherein entries on the first patient medical records (531, 631) have a time stamp, and the two- way firewall (110) is arranged to allow the first doctors access computer device (500) to display a patient record screen incorporating a historical overview of the patient's medical status based on the accessed patient's medical records (531, 631). (abstract discloses, “A System for processing data requests from clients via a network is disclosed. The System has an application Server coupled to a network, and a Semantic firewall to pass and filter the content between the application Server and the clients. The application Server provides content from a database to the clients via the network, and the Semantic firewall restricts access to a portion of the content for one or more clients.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s teachings with Callahan’s teachings for the same reasons given for claim 1.
However Callahan also does not teach the underlined portion:
The medical record system (10) according to claim 1, wherein entries on the first patient medical records (531, 631) have a time stamp, and the two- way firewall (110) is arranged to allow the first doctors access computer device (500) to display a patient record screen incorporating a historical overview of the patient's medical status based on the accessed patient's medical records (531, 631).
However, Menschik does teach:
The medical record system (10) according to claim 1, wherein entries on the first patient medical records (531, 631) have a time stamp, and the two- way firewall (110) is arranged to allow the first doctors access computer device (500) to display a patient record screen incorporating a historical overview of the patient's medical status based on the accessed patient's medical records (531, 631). ([0093] discloses, “Table 224 of FIG. 8A, an example of how one form of patient records (in particular, diagnostic imaging results) may be Stored, is seen to include 2 records, 124-1 and 124-2, each record relating to a particular patient diagnostic imaging Study performed at hospital 162 and including Sixteen data fields, comprising: a unique patient report identifier (REPORT ID 224A), a patient identifier (PATIENT ID 224B), a medical record number (MRN 224C) unique to hospital 162, a patient name (PATIENT NAME 224D), a patient date of birth (PATIENT DOB 224E), a patient gender (PATIENT SEX 224F), an accession number, (ACCESSION NUM 224G) comprising a unique identifier from the RIS that is generated when the study is ordered and used by Some medical information Systems to call up the Status and results of a particular Study, a report Status indicator (REPORT STATUS 224H) indicating the completion status of a radiological report (i.e. f=finished, p=pre liminary), a modality indicator (MODALITY 2241) indicat ing the modality which acquired the images (e.g. CT, MR, etc.), a body part indicator (BODY PART 224J), a date indicating when the study was acquired (DATE PER FORMED 224K), a time indicating the time on the date the study was acquired (TIME PERFORMED 224L), the name of the primary radiologist who interpreted the study (RADI OLOGIST 224M), a name of a referring physician if any (REFERRING PHYSICIAN 224N), a medical history (HISTORY 2240) providing a brief indication for the study, and a text field (TEXT 124P) containing the text of the radiology report.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s teachings and Callahan’s teachings with Menschik’s teachings as Shelton discloses the use of layers of firewalls to protect patient data (e.g. see [0095] and see [0097]) and teaches the importance of being able to easily transfer medical data but the need protect it with adequate laws (in e.g. [0004]-[0017]), and Callahan teaches the use of semantic firewalls for improved privacy and protection of medical data as previously cited, and Menschik discloses the importance of protected integration and sharing of patient data (see e.g. [0006]) therefore the additional data with firewall in Menschik shown would be choice data and improve the ability to transfer medical data to provide improved patient care while improve following HIPAA laws.
Response to Arguments Regarding 35 U.S.C § 101 Rejections
Applicant’s arguments on pages 1-2 of remarks have been considered. Applicant argues the 35 U.S.C § 101 rejection should be withdrawn for the following reasons. Claims 1-7 are rejected, under 35 U.S.C. § 101, as allegedly being directed to an abstract idea without "significantly more". The Applicant acknowledges and respectfully traverses the raised anticipatory rejection in view of the following remarks.
The pending claims are directed to a specific, technical architecture for accessing and maintaining distributed medical records in which (i) a two-way firewall cooperates with (ii) a patient-side trusted doctor file and (iii) stored links to patient medical records residing in multiple, separate doctor databases, in order to control and secure access to those distributed records. This is not a claim to the abstract concept of "organizing human activity", but to a particular improvement in the way computer networks manage secure access to distributed medical data. In particular, claim 1 requires: . a first patient access computer device and first patient database; . first and second doctor access devices and corresponding, separate doctor
databases storing that doctor's patient medical records; . a cloud network interconnecting these devices and databases; and . a server including a two-way firewall which, subject to the first and second doctor being identified as trusted in a first patient trusted doctor file, (a) allows the patient device to obtain and store links to first patient medical records in the doctor databases and (b) allows the first doctor device to access those records through the stored links.
This cooperation of elements yields a technical solution to a technical problem: how to enable a patient to maintain control over access to their distributed medical records, which are stored in multiple, independent doctor databases, while still permitting trusted doctors to obtain a consolidated view through a controlled firewall path. None of the cited art discloses this arrangement, and the Examiner has not shown that it is "well-understood, routine or conventional". Unlike cases where generic computers merely implement a business practice, the claimed system restructures the architecture of medical record access: . The two-way firewall is not a generic gateway; it is configured so that both patient and doctor devices may access distributed medical records only when the doctor is present in the patient's trusted doctor file and only via links stored on the patient's database. . The trusted doctor file is a specific patient-side data structure that encodes trust relationships and is enforced by the firewall, rather than simply recording a consent event in a central system. . The stored links are technical pointers to particular patient medical records across multiple doctor databases; they implement a specific mechanism for aggregating distributed data without centralizing all records in one repository.
These features, in combination, provide a concrete improvement in computer functionality and network security in the medical records context, analogous to the kinds of technical improvements found eligible in decisions such as DDR Holdings and related Federal Circuit precedent. The claims therefore recite more than an abstract idea and, at a minimum, recite an "inventive concept" in their ordered combination. Applicant respectfully submits that the §101 rejection should be withdrawn.
Examiner appreciates applicant’s arguments but respectfully does not find them persuasive. The MPEP states The Alice/Mayo two-part test is the only test that should be used to evaluate the eligibility of claims under examination. While the machine-or-transformation test is an important clue to eligibility, it should not be used as a separate test for eligibility. Instead it should be considered as part of the "integration" determination or "significantly more" determination articulated in the Alice/Mayo test. Bilski v. Kappos, 561 U.S. 593, 605, 95 USPQ2d 1001, 1007 (2010). See MPEP § 2106.04(d) for more information about evaluating whether a claim reciting a judicial exception is integrated into a practical application and MPEP § 2106.05(b) and MPEP § 2106.05(c) for more information about how the machine-or-transformation test fits into the Alice/Mayo two-part framework.
The enumerated groupings of abstract ideas are defined as:
1) Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I); (Mathematical Calculations - A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.)
2) Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP § 2106.04(a)(2), subsection II); and
3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
Examiners should determine whether a claim recites an abstract idea by (1) identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea, and (2) determining whether the identified limitations(s) fall within at least one of the groupings of abstract ideas listed above. Furthermore, the MPEP state in 2106.04(d), “Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical applications.”
The positively recited claim 1 (as representative) is directed to a judicial exception (i.e. certain methods of organizing human activity) as it is following rules and instructions to access patient medical records this is abstract in substance as a human with or without the aid of a computer environment can determine based on abstract reasoning or aids whether data is able to be accessed or maintained by certain doctors and patients. If applicants reasoning were correct Alice Corp. would have been found eligible. Being implemented by a computer environment automatically does not make the recited claim dispositive of being certain methods of organizing human activity. Furthermore, the claim is taken at its broadest reasonable interpretation based on claim construction and the specification is not read into the claims and its not would a human do it but could a human do it and it is not dispositive of being an abstract idea just because computer elements are used. The claim construction is broad with no further limiting elements themselves that would indicate the claim is not directed to an abstract idea of access management of medical records.
Further responding to applicants arguments, the judicial exception (abstract idea) cannot integrate itself into a practical application but identification of any additional elements recited in the claim can be evaluated to determine if the additional elements integrate the exception into a practical application. The claims additional elements are not recited as being an improvement to a technology field or a technology confined to the computer environment in which the claims recite. A technical problem must first be identified in instant application specification and reflected in the claims. Problems recited in the arguments are abstract problems related to record access and management. There are no additional elements recited other than the applied computer elements. The additional elements are apply it and the claims do not recite technical improvements to the computer or firewall or links or other technology confined to the general purpose computer environment whether alone or as a whole, rather these elements are applied to the abstract idea. Further the claim does not reflect or recite improvement to network security as the claim recites arrangement of computer elements as “apply-it” to more efficiently access or manage patient records but there is no improvement to the actual additional elements brought forth which make up “network security” such as the firewall for example rather these security elements are again applied to the abstract idea and alone or in combination with the abstract idea cannot bring forth the practical application as just “apply-it” and therefore also cannot bring forth significantly more. The instant application also has no nexus with DDR Holdings as the subject matter and claim construction were wholly different. Examiner notes 2106.05 states novelty of any element or process or steps arranged is of no consequence to eligibility analysis. Further well understood routine and conventional consideration may be considered by examiner if overlap exists but is not required and further is only analyzed for the additional elements not the abstract idea therefore examiner completed the analysis as required with the additional elements and further in 2B the analysis was completed as set forth in the MPEP 2106 which the additional elements are characterized as “apply-it” and the MPEP states thus cannot provide significantly more. Examiner maintains the claims are directed to an abstract idea and do not integrate into a practical application. Therefore, they also do not amount to significantly more.
Examiner maintains the 35 U.S.C § 101 rejection
Response to Arguments Regarding 35 U.S.C § 102/103 Rejections
Applicant’s arguments on pages 3-7 of remarks have been considered. Applicant argues the 35 U.S.C § 102/103 rejection should be withdrawn for the following reasons: A. Independent Claim 1 - Shelton and Callahan Do Not Teach the Claimed Features. The Examiner maps the limitations of claim 1 primarily to Shelton, relying on Callahan for the "two-way firewall" and for treating Callahan's "stored rules and definitions" as "stored links". This reading is inconsistent with the actual disclosures of Shelton and Callahan. "First patient trusted doctor file (230)" - Not Taught or Suggested Claim 1 requires that the two-way firewall operates "subject to the first doctor and second doctor being identified as a trusted doctor in a first patient trusted doctor file (230)". Shelton discloses an internet/intranet-based standing order database search system where an Approvals Agent manages requests for confidential records and obtains approvals from various parties. While Shelton discusses informed consent and "standing provisions" for release of records, those approvals are managed centrally by the Approvals Agent and the database administrator, not through a patient-side trusted doctor file stored on a patient database and enforced by a firewall. The Examiner's characterization of Shelton's consent mechanisms as a "trusted doctor file" stretches the reference beyond its disclosure. Callahan discloses a semantic firewall that applies rule-based access control to XML content. In one example, rules distinguish between a patient's own physician and other physicians, assigning different "view" or "edit" rights to individual XML fields. However, these rules are encoded in a rule engine and style sheets; there is no patient-maintained trusted doctor file that enumerates trusted doctors for a given patient, nor is there disclosure of such a file residing on a patient database. The rule engine is part of the server-side semantic firewall, not a patient-side trust list. Accordingly, neither Shelton nor Callahan teaches or suggests the specific "first patient trusted doctor file (230)" as claimed.
Examiner appreciates applicant’s arguments but does not find them persuasive. The claims are interpreted based on the claim construction and language in light of the specification, but the specification is not read into the claims. Further, if no specific limiting definition is given for a term claimed then examiner takes the plain definition as one of ordinary skill in the art would understand. The claim 1 is broad in its construction and the limitation reciting "subject to the first doctor and second doctor being identified as a trusted doctor in a first patient trusted doctor file (230)" examiner notes is cited as being taught by Callahan. Callahan teaches in paragraph [0072] which discloses, “An example of a raw CLIPS rule, i.e. the textual computer program, used to create the file in FIG. 10 is shown in FIG. 11. The rule mentioned above is expressed as a CLIPS rule in the system and is used to guide the transformation process of the XML content produced by the NAS. A rule consists of conditions on the left-hand-side (LHS) of the "=>” symbol and actions on the right-hand-side (RHS) of the “=>” symbol. XML content is processed into a tuple Space. If all conditions match on the LHS of a rule, the rule “fires”, and the actions on the RHS are performed. For example, lines 1104, 1106, 1108, and 1110 represent patterns within the condition of a rule (called rule6). Each pattern contains fixed content or variables. The elements NAME, POSITION and Physician in line 1106 are fixed, while the term “ename” is a variable. Variables match any fixed content of a corresponding tuple in the tuple Space (such as the tuple “(EMPLOYEES-EMPLOYEE (NAME Fred) (POSITION Physician))” from the XML content Scanned into the System). Some variables can match none, one, or any number of terms in a tuple. For example, the variable Srules in line 1110 matches the list of rules that are currently active. Named variables are bound to their values on the entire LHS of a rule. For example, if line 1104 matches the tuple “(SESSIONS-SESSION (NAME Fred))”, line 1106 must match the tuple “(EMPLOYEES-EM PLOYEE (NAME Fred) (POSITION Physician))” in the tuple Space. If Such a tuple does not exist, the entire rule fails to fire because it does not apply. Thus, the rule in FIG. 11 is interpreted as “for the current logged-in user whose name is ename (line 1104), and who is a Physician (line 1106), and not the patient's assigned physician (“-lename” means “NOT EQUAL to ?ename” in line 1108), and not yet under application of this rule (line 1110) (this rule cannot be applied more than once), set the ACCESS attribute to VIEW (line 1112) in the current patient for the fields PID, FNAME, LNAME, BADDRESS, BCITY, BSTATE, BZIP, BPHONE, and LASTVISIT (line 1114).” Line 1116 creates and stores the definition of rule6 in the rules for patients. Other rules (not shown) mark the ACCESS attribute to “none” or "edit” as their conditions dictate, while still other rules delete XML nodes during the transformation from FIG. 9 to the content in FIG. 10 such as INSURER, INSNUM, DOCTOR, VIS ITTIME, PURPOSE, SEENBY, and DIAGNOSIS.” And see [0081] discloses, “The XML fragment shown in FIG. 17 is passed as input to the Second Stage. The Second Stage applies complex Security rules in order to transform the input by adding, deleting, or changing tags, attributes, nodes, and node con tent. In this example, the Second Stage adds a view attribute to each record to indicate which records should be shown or hidden by the next stage in the pipeline. The Second Stage adds the view attribute to the Status tag of each record based on two rules: Rule 1-All physicians can See the list of patient records, Rule 2-Only the physician of the patient can view a medical test record for that patient.” And see [0082] discloses, “Based on these rules, the second stage produces the XML fragment 1802 shown in FIG. 18 as output. The status element 1804 of the first record 1806, the test result for Smith, can be viewed by the current user, Jones, because (1) Jones is a physician and can view all the records according to Rule 1, and (2) Jones is the physician for Smith in accord with Rule 2. The view attribute of the status element 1808 of the second record 1810, which is the test result for patient Morgan, is marked "false' because even though Jones is a physician, Jones is not the physician for Morgan.”)” Therefore examiner notes the interpretation of the limitation is that the doctors need to be trusted doctors for the patient files therefore they are a part of a patient trusted doctor file as the doctor is trusted and the doctor of that patient with access to their information and clearly Callahan teaches security rules for all physicians meaning plural of more than one which is atheist two where there is examples given of trusted doctors for patient file based on these security rules therefore claim limitation is taught as one or ordinary skill would understood at the broad level in which the limitation is claimed.
Examiner maintains the 103 for this limitation.
Applicant further argues that "Stored links (251, 261)" on the Patient Database - Not Taught or Suggested stating claim 1 further requires that, subject to the trusted doctor file, the two-way firewall allows the patient access device "to obtain and store links (251, 261) for accessing first patient medical records (531, 631) associated with the first patient" and allows the first doctor access device "to access the first patient medical records (531, 631) ... through the stored links". In the present invention, these "links" are technical pointers that identify the locations of the patient's records in the respective doctor databases (510, 610) and are stored in the patient database, enabling the patient to aggregate access to records distributed across multiple doctors.
Shelton does not disclose such links stored on a patient database. Shelton's system is built around a central Master Index and Approvals Agent; the repositories ("Legacy Databases 21") remain under the control of their administrators, and records are delivered after approvals via various channels. Shelton does not teach that a patient device obtains and stores links pointing into multiple, separate doctor databases for later access by doctors via a firewall. Callahan's "stored rules and definitions" are also not "links". Callahan explains that the rules are CLIPS rules that, when fired, set ACCESS attributes on XML elements and are used to generate XSLT style sheets to filter which fields are viewable or editable. Nowhere does Callahan disclose pointers or hyperlinks to remote patient records stored in multiple doctor databases. Treating Callahan's rules as "stored links" conflates two fundamentally different concepts: access-control rules versus data-location pointers. The Examiner's mapping of Callahan's "rules and definitions" to the claimed "links (251, 261)" is therefore in error.
Examiner appreciates applicant’s arguments but does not find them persuasive. The claims are interpreted based on the claim construction and language in light of the specification, but the specification is not read into the claims. Further, if no specific limiting definition is given for a term claimed then examiner takes the plain definition as one of ordinary skill in the art would understand. The claim 1 is broad in its construction and the limitation reciting "to obtain and store links (251, 261) for accessing first patient medical records (531, 631) associated with the first patient" examiner notes is cited as being taught by Callahan. Callahan teaches in paragraph [0072] which discloses, “An example of a raw CLIPS rule, i.e. the textual computer program, used to create the file in FIG. 10 is shown in FIG. 11. The rule mentioned above is expressed as a CLIPS rule in the system and is used to guide the transformation process of the XML content produced by the NAS. A rule consists of conditions on the left-hand-side (LHS) of the "=>” symbol and actions on the right-hand-side (RHS) of the “=>” symbol. XML content is processed into a tuple Space. If all conditions match on the LHS of a rule, the rule “fires”, and the actions on the RHS are performed. For example, lines 1104, 1106, 1108, and 1110 represent patterns within the condition of a rule (called rule6). Each pattern contains fixed content or variables. The elements NAME, POSITION and Physician in line 1106 are fixed, while the term “ename” is a variable. Variables match any fixed content of a corresponding tuple in the tuple Space (such as the tuple “(EMPLOYEES-EMPLOYEE (NAME Fred) (POSITION Physician))” from the XML content Scanned into the System). Some variables can match none, one, or any number of terms in a tuple. For example, the variable Srules in line 1110 matches the list of rules that are currently active. Named variables are bound to their values on the entire LHS of a rule. For example, if line 1104 matches the tuple “(SESSIONS-SESSION (NAME Fred))”, line 1106 must match the tuple “(EMPLOYEES-EM PLOYEE (NAME Fred) (POSITION Physician))” in the tuple Space. If Such a tuple does not exist, the entire rule fails to fire because it does not apply. Thus, the rule in FIG. 11 is interpreted as “for the current logged-in user whose name is ename (line 1104), and who is a Physician (line 1106), and not the patient's assigned physician (“-lename” means “NOT EQUAL to ?ename” in line 1108), and not yet under application of this rule (line 1110) (this rule cannot be applied more than once), set the ACCESS attribute to VIEW (line 1112) in the current patient for the fields PID, FNAME, LNAME, BADDRESS, BCITY, BSTATE, BZIP, BPHONE, and LASTVISIT (line 1114).” Line 1116 creates and stores the definition of rule6 in the rules for patients. Other rules (not shown) mark the ACCESS attribute to “none” or "edit” as their conditions dictate, while still other rules delete XML nodes during the transformation from FIG. 9 to the content in FIG. 10 such as INSURER, INSNUM, DOCTOR, VIS ITTIME, PURPOSE, SEENBY, and DIAGNOSIS.” And see [0081] discloses, “The XML fragment shown in FIG. 17 is passed as input to the Second Stage. The Second Stage applies complex Security rules in order to transform the input by adding, deleting, or changing tags, attributes, nodes, and node con tent. In this example, the Second Stage adds a view attribute to each record to indicate which records should be shown or hidden by the next stage in the pipeline. The Second Stage adds the view attribute to the Status tag of each record based on two rules: Rule 1-All physicians can See the list of patient records, Rule 2-Only the physician of the patient can view a medical test record for that patient.” And see [0082] discloses, “Based on these rules, the second stage produces the XML fragment 1802 shown in FIG. 18 as output. The status element 1804 of the first record 1806, the test result for Smith, can be viewed by the current user, Jones, because (1) Jones is a physician and can view all the records according to Rule 1, and (2) Jones is the physician for Smith in accord with Rule 2. The view attribute of the status element 1808 of the second record 1810, which is the test result for patient Morgan, is marked "false' because even though Jones is a physician, Jones is not the physician for Morgan.”)” Therefore examiner notes the interpretation of the limitation is that there needs to be obtained and stored links which are interpreted as information which digitally points the user to documentation and clearly Callahan teaches output XML which digitally points and allows access to patient information based on rules therefore claim limitation is taught as one or ordinary skill would understood at the broad level in which the limitation is claimed as there is no specific type of digital link claimed or how it is structured or operates within the claim.
Examiner maintains the 103 for this limitation.
Further applicant argues the Two-Way Firewall with the Claimed Function - Not Taught
By stating that the examiner relies on Callahan's semantic firewall 312 for the "two-way firewall (110)". Callahan indeed describes a firewall that "passes and filters the content between the application server and the clients", using data-dependent rules. However, Callahan's firewall simply filters XML content based on rules; it is not configured, as in claim 1, to: consult a patient trusted doctor file on a patient database; and thereby both (a) permit the patient device to obtain and store links to records in multiple doctor databases, and (b) permit a doctor device to access those records through those stored links. Callahan's firewall neither accesses a patient-side trusted doctor file nor manages any links on a patient database. Its function is fundamentally different: field-level content filtering for a given request, not management of link-based access to distributed databases. Thus, even if Callahan's semantic firewall were combined with Shelton's system, the result would be a content-filtering layer in front of Shelton's central system, not the specific two-way firewall + patient trusted doctor file + stored link architecture recited in claim 1.
Examiner appreciates applicant’s arguments but does not find them persuasive. The claims are interpreted based on the claim construction and language in light of the specification, but the specification is not read into the claims. Further, if no specific limiting definition is given for a term claimed then examiner takes the plain definition as one of ordinary skill in the art would understand. The claim 1 is broad in its construction and the limitation reciting "two-way firewall (110)" is taken by plain definition as no specific type of two way firewall defined in the drawings or the specification rather it is claimed as a firewall which monitors incoming and outgoing traffic examiner notes this is cited as being taught by Callahan. Callahan teaches in abstract which discloses, “A System for processing data requests from clients via a network is disclosed. The System has an application Server coupled to a network, and a Semantic firewall to pass and filter the content between the application Server and the clients. The application Server provides content from a database to the clients via the network, and the Semantic firewall restricts access to a portion of the content for one or more clients.” Therefore examiner notes under BRI the semantic firewall in Callahan is monitoring based on access ingoing and outgoing content between a server and one or more clients thus teaches the element as there as a semantic firewall can be a two way firewall if monitoring incoming and outgoing information.
Examiner maintains the 103 for this limitation.
Applicant further argues No Proper Motivation to Combine Shelton and Callahan to Arrive at the Claimed Arrangement by stating the examiner asserts that it would have been obvious to combine Shelton's system with Callahan's firewall to improve security and address HIPAA concerns. While improving security is a general motivation, it does not explain why the skilled person would radically reorganize Shelton's central, administrator-controlled architecture into Applicant's patient-centric, link-based architecture. Shelton is designed around: . a central Master Index and Approvals Agent, . a Request Cache physically separated from the Legacy Database,
. and a data administrator who retains control over document release and transmission.
Callahan, in turn, is designed to offload content filtering and data-dependent access decisions into a semantic firewall and rule engine. Applicant's invention, by contrast, places control with the patient device, which maintains a trusted doctor file and stored links to distributed doctor databases, and uses a two-way firewall to enforce these patient-defined trust relationships when both patient and doctor devices access the distributed records. Moving from Shelton's centrally managed, administrator-controlled model to Applicant's decentralized, patient-centric, link-managed model would require more than simply "adding a firewall" as a design choice; it would require substantial redesign that the cited art does not suggest.
Accordingly, there is no proper rationale that would lead the skilled person from Shelton and Callahan to the specific arrangement claimed.
Examiner appreciates applicant’s arguments but does not find them persuasive. The claims are interpreted based on the claim construction and language in light of the specification, but the specification is not read into the claims. Further, if no specific limiting definition is given for a term claimed then examiner takes the plain definition as one of ordinary skill in the art would understand. The claim 1 is broad in its construction and the argued information is not reflected in the claims there is no specific architecture claimed other than broadly a two way firewall and data from databases for manipulation with computer elements therefore the motivation to combine may be “general” in its nature but the instant application claim mirrors this level of generality and there is no indication by the recited claims that a substantial redesign is needed to combine the art of record to teach the broad limitations of claim 1. Further, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, monitoring and securing access to documentation is the teaching and motivation to combine at the broad level in which the claim language recites the arrangement of steps.
Examiner maintains the 103 for this limitation.
Further applicant argues Claim 2 - Menschik Does Not Cure the Deficiencies left by the other prior Art that claim 2 depends from claim 1 and adds timestamped entries and a historical overview of the patient's medical status. The Examiner cites Menschik for timestamps and historical views. Applicant does not contest that timestamps and history views may be known. However, Menschik's disclosure does not remedy the deficiencies identified above for claim 1.. Menschik discloses distributed agents associated with providers, which periodically collect local information and send metadata to a central system, where records are grouped and patients can authorize access and peer-to-peer transfer of original data. . Menschik does not disclose a patient trusted doctor file stored on a patient database, stored links on the patient device pointing into multiple doctor databases, or a two-way firewall enforcing these features. Thus, even in view of Menschik, the combination still fails to teach or suggest the core limitations of claim 1, and dependent claim 2 remains non-obvious.
Examiner appreciates applicant’s arguments but does not find them persuasive. The claims are interpreted based on the claim construction and language in light of the specification, but the specification is not read into the claims. Further, if no specific limiting definition is given for a term claimed then examiner takes the plain definition as one of ordinary skill in the art would understand. Menschik is not argued to not teach the limitations it is cited for thus examiner finds no argument to respond to. Rather examiner notes the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Examiner maintains the 103 for this limitation.
Applicant further argues dependent Claims 3-7 - Additional Limitations Not Taught because the examiner further relies on Callahan to reject claims 3-6 and on Callahan in combination with Shelton to reject claim 7. Claim 3 recites that the two-way firewall prohibits the first doctor device from changing second doctor's medical records on the second doctor database. Callahan's firewall can mark fields as view-only or editable, but it operates at the level of XML content once retrieved from the database; it does not govern whether a given doctor can modify another doctor's records in a separate doctor database.
Examiner appreciates applicant’s arguments but does not find them persuasive. The claims are interpreted based on the claim construction and language in light of the specification, but the specification is not read into the claims. Further, if no specific limiting definition is given for a term claimed then examiner takes the plain definition as one of ordinary skill in the art would understand. Claim 3 recites, “The medical record system (10) according to claim 1, wherein the two- way firewall (110) is arranged to prohibit the first doctor access device (500) to change second doctor's medical records (631, 633) on second doctor database (610).” And examiner cited Callahan as teaching in paragraph [0071] which discloses, “A rule used to transform the file in FIG. 9 is shown in FIG. 11. The rule is: a physician who is not the patient's own physician (e.g., another doctor at the hospital) is allowed to view billing address information and edit the follow-up visit date and time. In accordance with this rule, field 906 becomes field 1006, having an additional attribute of access="view”, meaning that the field is viewable by the user who is a physician. Similarly, field 908 becomes field 1008 and is viewable by the user; and field 910 becomes field 1010 having the attribute of being editable by the user. The date of the next follow-up visit is also incremented by approximately one month, taking into account holidays and weekends. The remaining fields in 904 are similarly processed based on the rules.” And see [0081]-[0082]” Therefore examiner notes under BRI someone of ordinary skill in the art would understand the claim is stating the firewall is arranged to prohibit for one doctor to change another doctors medical records and Callahan clearly teaches rules of either access/view or edit are set as needed for doctors who aren’t the patients doctor or who art he patients doctor respectively therefore the semantic firewall is arranged to prohibit access when needed and matches the intended use broad way the claim is constructed.
Examiner maintains the 103 for this limitation.
Applicant further argues claim 4 recites a separation of patient-record part and physician-record part in the medical records, with the firewall allowing patient devices to access only the patient-record part. Callahan's ACCESS attributes can hide or show fields, but there is no explicit notion of splitting each record into a "patient part" and "physician part" as structurally distinct components enforced by the firewall in the claimed environment.
Examiner appreciates applicant’s arguments but does not find them persuasive. The claims are interpreted based on the claim construction and language in light of the specification, but the specification is not read into the claims. Further, if no specific limiting definition is given for a term claimed then examiner takes the plain definition as one of ordinary skill in the art would understand. Claim 4 recites, “The medical record system (10) according to claim 1, wherein patient medical records (531, 532, 631, 633, 732, 733) comprise a patient-record part and a physician-record part, and the two-way firewall (110) is arranged to allow the patient's access device (200, 300, 400) access to the patient-record part and arranged to prohibit access to the physician-record part of the medical records associated with the respective patient.” and Callahan recites in paragraph [0071] which discloses, “A rule used to transform the file in FIG. 9 is shown in FIG. 11. The rule is: a physician who is not the patient's own physician (e.g., another doctor at the hospital) is allowed to view billing address information and edit the follow-up visit date and time. In accordance with this rule, field 906 becomes field 1006, having an additional attribute of access="view”, meaning that the field is viewable by the user who is a physician. Similarly, field 908 becomes field 1008 and is viewable by the user; and field 910 becomes field 1010 having the attribute of being editable by the user. The date of the next follow-up visit is also incremented by approximately one month, taking into account holidays and weekends. The remaining fields in 904 are similarly processed based on the rules. 0072 An example of a raw CLIPS rule, i.e. the textual computer program, used to create the file in FIG. 10 is shown in FIG. 11. The rule mentioned above is expressed as a CLIPS rule in the system and is used to guide the transformation process of the XML content produced by the NAS. A rule consists of conditions on the left-hand-side (LHS) of the "=>” symbol and actions on the right-hand-side (RHS) of the “=>” symbol. XML content is processed into a tuple Space. If all conditions match on the LHS of a rule, the rule “fires”, and the actions on the RHS are performed. For example, lines 1104, 1106, 1108, and 1110 represent patterns within the condition of a rule (called rule6). Each pattern contains fixed content or variables. The elements NAME, POSITION and Physician in line 1106 are fixed, while the term “ename” is a variable. Variables match any fixed content of a corresponding tuple in the tuple Space (such as the tuple “(EMPLOYEES-EMPLOYEE (NAME Fred) (POSITION Physician))” from the XML content Scanned into the System). Some variables can match none, one, or any number of terms in a tuple. For example, the variables rules in line 1110 matches the list of rules that are currently active. Named variables are bound to their values on the entire LHS of a rule. For example, if line 1104 matches the tuple “(SESSIONS-SESSION (NAME Fred))”, line 1106 must match the tuple “(EMPLOYEES-EM PLOYEE (NAME Fred) (POSITION Physician))” in the tuple Space. If Such a tuple does not exist, the entire rule fails to fire because it does not apply. Thus, the rule in FIG. 11 is interpreted as “for the current logged-in user whose name is ename (line 1104), and who is a Physician (line 1106), and not the patient's assigned physician (“-lename” means “NOT EQUAL to ?ename” in line 1108), and not yet under application of this rule (line 1110) (this rule cannot be applied more than once), set the ACCESS attribute to VIEW (line 1112) in the current patient for the fields PID, FNAME, LNAME, BADDRESS, BCITY, BSTATE, BZIP, BPHONE, and LASTVISIT (line 1114).” Therefore examiner notes “a patient record part” a “physician record part” is very broad as no specifics are limited under this meaning. Under BRI someone of ordinary skill in the art would understand the claim is stating the firewall is arranged to prohibit access to only certain patient or physician for e.g. the email and demographic information which is considered part of patient recorded information. Examiner also notes that the firewall contains rules able to allow patients or physicians access to specific information based on those rules therefore clearly Callahan clearly teaches the claim and matches the broad way the claim is constructed.
Examiner maintains the 103 for this limitation.
Applicant further argues claim 5 further restricts access to both parts to doctors identified as trusted in the patient's trusted doctor record. As explained, neither Shelton nor Callahan teaches such a patient trusted doctor record. Claim 6 requires that the two-way firewall is arranged as a distributed firewall. The Examiner cites Callahan as implying a distributed configuration. However, Callahan primarily discloses a semantic firewall located between server and clients; a truly "distributed firewall" in the sense of claim 6 (e.g., with firewall components associated with multiple devices/databases in the claimed architecture) is not clearly taught.
Examiner appreciates applicant’s arguments but does not find them persuasive. The claims are interpreted based on the claim construction and language in light of the specification, but the specification is not read into the claims. Further, if no specific limiting definition is given for a term claimed then examiner takes the plain definition as one of ordinary skill in the art would understand. Claim 5 recites, “The medical record system (10) according to claim 4, wherein both the patient-record part and physician-record part of a patient's medical record (531, 532, 631, 633) are accessible to a doctor access device (500, 600, 700), subject to the doctor being identified as trusted in the respective patient's trusted doctor record (230, 330, 430).” And Callahan teaches in paragraph [0081] which discloses, “The XML fragment shown in FIG. 17 is passed as input to the Second Stage. The Second Stage applies complex Security rules in order to transform the input by adding, deleting, or changing tags, attributes, nodes, and node con tent. In this example, the Second Stage adds a view attribute to each record to indicate which records should be shown or hidden by the next stage in the pipeline. The Second Stage adds the view attribute to the Status tag of each record based on two rules: Rule 1-All physicians can See the list of patient records, Rule 2-Only the physician of the patient can view a medical test record for that patient.” And see [0082] discloses, “Based on these rules, the second stage produces the XML fragment 1802 shown in FIG. 18 as output. The status element 1804 of the first record 1806, the test result for Smith, can be viewed by the current user, Jones, because (1) Jones is a physician and can view all the records according to Rule 1, and (2) Jones is the physician for Smith in accord with Rule 2. The view attribute of the status element 1808 of the second record 1810, which is the test result for patient Morgan, is marked "false' because even though Jones is a physician, Jones is not the physician for Morgan.” Therefore examiner notes “a patient record part” a “physician record part” is very broad as no specifics are limited under this meaning. Under BRI someone of ordinary skill in the art would understand the claim is stating the firewall is arranged to prohibit access to only certain patient or physician for e.g. the email and demographic information which is considered part of patient recorded information. Examiner also notes that the firewall contains rules able to allow patients or trusted physicians access to specific information based on those rules therefore clearly Callahan clearly teaches the claim and matches the broad way the claim is constructed.
Examiner maintains the 103 for this limitation.
Applicant further argues claim 7 recites method steps corresponding to claim 1. For the reasons set out above for claim 1, the combination of Shelton and Callahan does not teach or suggest these method steps, particularly the steps of storing the patient trusted doctor file on the patient database, obtaining and storing links on the patient device, and doctor access via those stored links subject to the trusted doctor file. Accordingly, claims 3-7 are likewise non-obvious.
Examiner does not find this argument persuasive. Examiner maintains the 103 for this limitation for all the reasons aforementioned and argued by examiner.
Prior Art not cited but made of record
US12223094B1- Rudolph
Disclosed herein are systems and methods for storing patient medical information on a local processing device, anonymizing a portion of that medical information and storing it on a second processing device, exposing that anonymized medical information to a third processing device coupled to the second processing device through a network, and restricting users of the third processing device to only accessing HIPAA compliant medical information. Alarms are included for indicating the improper transfer of HIPАА data.
US20200203025A1 – Kaira et. al
A secure , reliable telehealth delivery platform that also provides flexibility and scalability . The platform includes a plurality of geographically dispersed communication servers that facilitate communication sessions between remotely located patients and healthcare providers over a public communications network . The platform includes a connectivity server that manages access among users and locations . The platform also includes a monitoring server that monitors the health and usage of devices coupled to the network and proactively identifies issues requiring intervention before service interruptions occur . That platform may also provide clients in heavily - restricted network environments with seamless access to multiple third - party web service providers
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
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/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687