Notice of Pre-AIA or AIA Status
1. 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 Arguments
2. Applicant’s arguments filed on 08/13/2026, with respect to the 35 U.S.C 103 rejections of claims 1-3, 5,6, 9-11, 13, 14, 17, 22, and 27 as being unpatentable over U.S. Publication No. 20170372096 hereinafter Yousfi in view of U.S. Publication No. 20090132282 hereinafter Kerstna, and further in view of U.S. Patent No. 10485489 hereinafter Belle have been fully considered. However, upon further consideration, a new ground(s) of rejection is made in view of amended claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The 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.
3. Claims 1-3, 5,6, 9-11, 13, 14, 17, 22, and 27 are rejected under 35 U.S.C. 103
as being unpatentable over U.S. Publication No. 20170372096 hereinafter Yousfi in
view of U.S. Publication No. 20090132282 hereinafter Kerstna, and further in view of
U.S. Publication No. 20150149208 hereinafter Lynch.
As to claim 1, Yousfi discloses:
A medical data management system (Fig 1 element 100 para 0042)
for managing medical data (para 0042), the system comprising:
a medical data gateway (Fig 1 element 113)
including at least one processor (Fig 1 element 115)
connectable to a plurality of input devices (Fig 1110)
the medical data gateway being connected to a local network
(Fig 3A element 313, para 0065 and 0070)
and the at least one processor being configured to carry out at least:
collecting medical data associated to health data may include patient
information with patient privacy information a non- pseudonymized patient
identifier (para 0024 and 0028)
and a data source identifier, from an input device of the plurality of
input devices (para 0024, 0035 and 0044)
pseudonymize at least the non-pseudonymized patient identifier
to produce pseudonymized medical data (para 0024, 0042 and 0058)
including a pseudonymized patient identifier based on the non-
pseudonymized patient identifier (para 0035 "Alternately or in addition, hashes of
patient privacy information may be generated or used to anonymously link patient
privacy information to an identifier. For example, a selected patient's patient
privacy information serve as input for a hash function, and the hash function may
output a hash. The hash may be mapped to the input patient privacy information,
even if the hash does not include patient privacy information. In one embodiment,
the hash function may be an irreversible hash function that may omit patient
privacy information. Exemplary hash functions include SHA1, MD5, berypt, etc.
Any hash function may be used, but the same hash algorithm may be used on
each case, so that different data sets may be mapped to one another. In one
embodiment, hashes may include unique values computed for each of the fields
considered patient privacy data. Any field of the patient privacy information may
be hashed. Exemplary hashed fields may include: patient's first name, patient's
last name, a patient identifier (e.g., patient ID), a patient's date of birth, a referring
physician's first name, a referring physician's last name, a study date, a study
time, etc." Para 0059 "In one embodiment, step 203 may include anonymizing
the collected health data. For example, a cloud platform of the first region may
strip the received health data of PHI. In one embodiment, step 203 may further
include storing the PHI stripped from a received health data set, e.g., in a PHI
database of the first region. In one embodiment, the PHI database may be
included in a cloud platform, a local network, or any system of the first region. For
example, step 203 may include identifying PHI fields based on regulatory
requirements of the first region. For instance, in a DICOM file, step 203 may
include detecting the Patient Name field (e.g., Tag (0010,0010), identifying the
patient name, storing the patient name (e.g., in a database), and redacting the
name from the DICOM with a generic (e.g., not nominative) string." Para 0059 "In
one embodiment, step 205 may include creating one or more hashes of the PHI.
Adding a hash may include computing and/or storing a hash (ea., at a permanent
storage). The hashes may be irreversible and created so they do not contain
PHI. Accordingly, while the PHI may be retained in the first region, the hashes
may be transferred to the second region along with the data (now decoupled
from PHI). In other words, method 200 may entail ensuring that PHI associated
with the health data may remain in the first region, while the health data (absent
PHI) and the hash may be transmitted to the second region. Accordingly, step
207 may include transmitting anonymized health data to a second region. For
example, transmitted health data may be associated with one or more hashes or
other identifiers, while PHI remains exclusively within the first region (e.g., in the
PHI storage).
export the pseudonymized medical data to a remote storage (Figs. 1, 3A
and 4a, 0050, 0058 and 0070)
and make the non-pseudonymized patient identifier patient privacy
information may include patient identification information accessible to a local
application one or more displays running in the local network (Fig 3A element
311, para 0095)
Yousfi does not disclose:
data source identifier corresponding to an identifier of the input device of
the plurality of input devices
a pseudonymized patient identifier created on the non-
pseudonymized patient identifier and the data source identifier
and make non-pseudonymized patient identifier non-accessible to a
remote application, running outside of a local network
Kerstna discloses:
and make non-pseudonymized patient identifier non-accessible to a
remote application, running outside of a local network (para 0068 "This
embodiment of the present invention, thus, allows external domains to access
medical data from a (isolated) patient domain, the patient identifiers of which are
inaccessible for the external domains and other external units." Para 0069 "In an
optional next step S11, the medical data and the received patient identifier is
associatively stored in a storage location within the first patient domain and/or the
medical data and patient identifier are sent, preferably through secure
communication, to an external storage location for storage therein.")
Therefore, it would have been obvious to one of ordinary skill in the art
before the effective filing date of the claimed invention to modify the preserving
patient privacy of Yousfi to include and make non-pseudonymized patient
identifier non-accessible to a remote application, running outside of a local
network, as taught by Kerstna.
The motivation would have been to enable exchange of medical and
Clinical patient data between patient domains in a healthcare system (Kerstna
paragraph 0012).
Yousfi in view Kerstna of does not disclose:
data source identifier corresponding to an identifier of the input device of
the plurality of input devices
a pseudonymized patient identifier created on the non-
pseudonymized patient identifier and the data source identifier
Lynch discloses:
data source identifier corresponding to an identifier of the input device of
the plurality of input devices (para 0029 “However, when multiple source systems are involved, for example a first source system and a second source system, because the source systems may be separate and independent, the second source system may assign a totally new MRN to the same patient whose records also exist in the first source system, as neither source system is privy to the information contained in the other source system.”)
a pseudonymized patient identifier created on the non-
pseudonymized patient identifier and the data source identifier (para 0026 “The enterprise data warehouse system 140 may include an ETL (extract, transform, and load) supervisor 250, which receives hashed patient identification data elements from the anonymizing hashing appliance 150. The ETL supervisor 250 may be operatively coupled to an AMPI server (anonymized master patient index) 254. The AMPI server 254 is configured to store the encrypted and anonymized patient records in an AMPI data component 260 or memory storage, and its main function is to generate a single identifier that essentially aggregates all qualifying anonymized patient records so as to identify or map all such records to a single anonymous patient.” para 0028 “ Thus, a particular source system 120 may supply to the hashing appliance 150, many records of a particular patient, which would all have the same MRN. Each record preferably includes a source identifier that identifies the source system that produced the record.”)
Therefore, it would have been obvious to one of ordinary skill in the art
before the effective filing date of the claimed invention to modify the preserving
patient privacy of Yousfi in view Kerstna to include data source identifier
corresponding to an identifier of the input device of the plurality of input devices
and a pseudonymized patient identifier based on the non-pseudonymized patient
identifier and the data source identifier as taught by Lynch.
The motivation would have been to properly identify source identifier of
input devices.
As to claim 2, Yousfi in view of Kerstna and Lynch discloses:
The system of claim 1, wherein the medical data gateway (Yousfi Fig 1
113) further comprises:
a storage (Yousfi Fig 1 element 117) and
the at least one processor is further configured to pseudonymized at least
one non- pseudonymized patient identifier (Yousfi para 0059)
associating the medical data to the pseudonymized patient identifier, and
storing the pseudonymized patient identifier and the non-pseudonymized patient
identifier in the storage (Yousfi para 0024, 0035, 0036, 004f9, 0059, and 0088)
As to claim 3, Yousfi in view of Kerstna and Lynch discloses:
The system of claim 1, wherein, the at least one processor is configured to
export the pseudonymized medical data by transferring the pseudonymized
medical data to the remote storage, and deleting the pseudonymized medical
data from the medical data gateway (Yousfi Fig 1 element 121 and Fig 4A
element, para 0048 and 0049).
As to claim 5, Yousfi in view of Kerstna and Lynch discloses:
The system of claim 1, wherein the at least one processor is configured to
receive a data availability notification, including the data source identifier and the
non-pseudonymized patient identifier (Yousfi para 0024 and 0033).
As per claim 6, Yousfi in view of Kerstna and Lynch discloses:
The system of claim 1, wherein the at least one processor is configured
receive a data query, including the data source identifier and the non-
pseudonymized patient identifier (Yousfi para 0062 "In one embodiment, step
217 may include transmitting analyzed data to the first region and step 219 may
include matching analyzed data to a patient. For example, step 219 may include
matching identifier(s) and/or hash(es) associated with the analyzed data, to
identifier(s) and/or hash(es) associated with PHI stored in the PHI database of
the first region.") and (Kerstna para 0076 and 0110, Though Yousfi discloses a
data query, Kerstna discloses receive a data query, including the data source
identifier and the non- pseudonymized patient identifier. The motivation would
have been to enable exchange of medical and Clinical patient data between
patient domains in a healthcare system ).
As per claim 9, the implementation of the system of claim 1 will execute the
medical management method of claim 1. The claim is analyzed with respect
to claim 1.
As per claim 10, the claim is analyzed with respect to claim 2.
As per claim 11, the claim is analyzed with respect to claim 3.
As per claim 13, the claim is analyzed with respect to claim 5.
As per claim 14, the claim is analyzed with respect to claim 6.
As per claim 17, the claim is analyzed with respect to claim 3.
As per claim 22, the claim is analyzed with respect to claim 3.
As per claim 27, the implementation of the system of claim 1 will execute
the non-transitory computer readable medium (Yousfi paragraph 0116) of
claim 1. The claim is analyzed with respect to claim 1.
4. Claim 4, 12, 18, and 23 is rejected under pre-AIA 35 U.S.C. 103 as being
unpatentable over Yousfi in view of Kerstna, further in view of Lynch, and further in
view of in view of U.S. Publication No. 20160154977 hereinafter Jagdish, and further in
view of U.S. Publication No. 20150012283 hereinafter Ryan.
As to claim 4, Yousfi in view of Kerstna and Lynch discloses:
The system of claim 1, wherein the at least one processor is configured to:
pseudonymized patient identifier (Yousfi para 0058)
Yousfi in view of Kerstna and Lynch does not disclose:
receive a conversion request including the pseudonymized patient
identifier,
evaluate whether the conversion request has sufficient rights for
obtaining the non-pseudonymized patient identifier, and
convert, upon the conversion request being evaluated to have the
sufficient rights for obtaining the non-pseudonymized patient identifier, the
pseudonymized patient identifier into the non-pseudonymized patient identifier
Jagdish discloses:
receive a conversion request, evaluate whether the conversion request
has sufficient rights for obtaining the non-pseudonymized patient identifier (para
0048 " When a user 117 logs in at the Client for viewing the patient data, a
decision is made on the basis of the login data, to download the encrypted
patient identification dataset or not." Para 0049 "The inbox 139 sends a request
to the access service 153 for downloading the encrypted patient identification
dataset, if the login data are admissible."),
convert, upon the conversion request being evaluated to have the
sufficient rights for obtaining the non-pseudonymized patient identifier, the
pseudonymized patient identifier into the non- pseudonymized patient identifier
(para 0037 "Consequently, the patient identification data are separated from the
DICON-files. The patient identification data of a study, (like name, age, sex, or
date of birth), are stored as separate JSON-file with encryption." para 0049 "The
inbox 139 sends a request to the access service 153 for downloading the
encrypted patient identification dataset, if the login data are admissible. The
access service 153 uses the storage access service 155 for downloading the
encrypted patient identification dataset. For the sake of performance, the
encrypted patient identification dataset may be deposited in a cache-storage.
The information in the patient identification dataset is decrypted only in the cache
of the browsers and returned to the inbox 139.")
Therefore, it would have been obvious to one of ordinary skill in the art
before the effective filing date of the claimed invention to modify the preserving
patient privacy of Yousfi in view of Kerstna and Lynch to include receive a
conversion request, evaluate whether the conversion request has sufficient rights
for obtaining the non-pseudonymized patient identifier and u convert, upon the
conversion request being evaluated to have the sufficient rights for obtaining the
non-pseudonymized patient identifier, the pseudonymized patient identifier into
the non- pseudonymized patient identifier, as taught by Jagdish.
The motivation would have been to protect patient identification data by
encryption and are still made available for authorized users (Jagdish paragraph
0006).
Yousfi in view of Kerstna, Lynch and Jagdish does not disclose:
receive a request including a pseudonymized patient identifier
Ryan discloses:
receive a conversion request including a pseudonymized patient identifier
(para 0067 "At block 1410, data reports are received. More specifically, one or
more data reports are received via a communications network, by an analytic
server, from one or more wireless device application providers that provide
wireless device applications to patients, each request comprising an anonymized
patient identifier that identifies the patient associated with the data report, and a
wireless device application identifier that identifies the wireless device application
associated with the data report.")
Therefore, it would have been obvious to one of ordinary skill in the art
before the effective filing date of the claimed invention to modify the preserving
patient privacy of Yousfi in view of Kerstna, Lynch and Jagdish to include
receive a request including a pseudonymized patient identifier, as taught by
Ryan.
The motivation would have been to send a request including
pseudonymized patient identifier in order to properly identify and protect patient
identification.
As per claim 12, the claim is analyzed with respect to claim 4.
As per claim 18, the claim is analyzed with respect to claim 4.
As per claim 23, the claim is analyzed with respect to claim 4.
5. Claims 7-8, 15-16, 20-21, and 24-26 are rejected under pre-AIA 35 U.S.C. 103(a)
as being unpatentable over Yousfi in view of Kerstna, and further in view of Lynch
and further in view of U.S. Publication No. 20180217947 hereinafter Rusen.
As to claim 7, Yousfi in view of Kerstna and Lynch discloses:
The system of claim 5, further comprising: at least one processor (Yousfi
Fig. 1, element 115)
Yousfi in view of Kerstna and Lynch does not disclose:
a multiplexer configured to connect the at least one processor to a second
input device of the plurality of input devices identified by the data source identifier
Rusen discloses:
a multiplexer configured to connect the at least one processor to a second
input device of the plurality of input devices identified by the data source identifier
(para 0024 "The peripherals are not limited to any particular type, and may
include such peripherals as: a timer, a UART, a voltage comparator, an
encryption engine, an analogue-to-digital converter (ADC), a digital-to-analogue
converter (DAC), a radio transmitter, a radio receiver, and so on. An event may
be signaled from a peripheral in response to any input, change of state,
satisfying of a criterion, etc., as will be familiar to one skilled in the art-for
example, when a timer reaches a target value. The tasks may be any function or
operation which can be performed by the peripheral, such as transmitting data
over an interface." para 0094 "Each of the channels has a similar set of
elements. The channel's EEP is connected to an event signal lookup table which
cross-references a set of peripheral event register addresses with an internal
event line identifier which relates to one of the inputs to a multiplexer (MUX) in
the PPI, associated with the channel. The PPI is configured to set the MUX to
select the input associated with the address contained in the EEP.")
Therefore, it would have been obvious to one of ordinary skill in the art
before the effective filing date of the claimed invention to modify the preserving
patient privacy of Yousfi in view of Kerstna and Lynch to include a
multiplexer configured to connect the at least one processor to an input device
identified by the data source identifier, as taught by Rusen.
The motivation would have been provide a system that properly identifies
channels and information within the system.
As to claim 7, Yousfi in view of Kerstna and Lynch discloses:
The system of claim 1, further comprising: at least one processor (Yousfi
Fig. 1, element 115)
Yousfi in view of Kerstna and Lynch does not disclose:
a demultiplexer, configured to connect the at least one processor to an
output device
Rusen discloses:
a demultiplexer, configured to connect the at least one processor to an
output device (para 0095 "Similarly, the channel's TEP is connected to a task
signal lookup table which cross-references a set of peripheral task register
addresses with an internal task line identifier which relates to one of the output of
a demultiplexer (DEMUX) in the PPI, associated with the channel. The PPI is
configured to set the DEMUX to select the output associated with the address
contained in the TEP.")
Therefore, it would have been obvious to one of ordinary skill in the art
before the effective filing date of the claimed invention to modify the preserving
patient privacy of Yousfi in view of Kerstna to include a demultiplexer, configured
to connect the at least one processor to an output device, as taught by Rusen.
The motivation would have been provide a system that properly identifies
channels and information within the system.
As per claim 15, the claim is analyzed with respect to claim 7.
As per claim 16, the claim is analyzed with respect to claim 8.
As per claim 20, the claim is analyzed with respect to claim 8.
As per claim 21, the claim is analyzed with respect to claim 8.
As per claim 24, the claim is analyzed with respect to claim 7.
As per claim 25, the claim is analyzed with respect to claim 8.
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 GARY S GRACIA whose telephone number is (571)270-5192. The examiner can normally be reached Monday-Friday 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Chea can be reached at 5712723951. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY S GRACIA/Primary Examiner, Art Unit 2499
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