Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. This Office Action is responsive to the communication filed 4/29/2025.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 4/29/2025 was filed after the mailing date of the instant application. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections – 35 USC 103
3. 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.
4. Claims 1-15 are rejected under 35 USC 103 as being unpatentable over Lee et al (US 2014/0194817) in view of Moskal et al (US 11,568,985).
Regarding claim 1, Lee et al teaches a protection system of or for a medical device for granting authorization releases to operators for carrying out authorization-dependent manipulations on the medical device (par [0006], which discloses granting and controlling authorization for users operating medical pumps), the protection system comprising:
at least one data memory in which a first data record is created, which contains data which identifies a plurality of hierarchy or authorization levels (par [0007], lines 10-22, which discloses recording authorization levels corresponding to individuals operating the medical pumps), to each of which specific or selectable manipulations are assigned or can be assigned (par [0060], lines 10-15, “each task 71 will be assigned to an authorization level indicating generally a class of individuals who are authorized to complete that task”), and in which a second data record is created which contains data which identifies a plurality of drugs and/or therapies, to which manipulations to be enabled are assigned or can be assigned in each case (par [0013], “drug dispense system database holding information about drugs to be dispensed”).
Lee et al does not explicitly teach an authorization release selection device which is configured to assign at least one of the plurality of hierarchy or authorization levels to an operator as a function of an authorization certificate of the operator, and to enable only those manipulations assigned to the at least one of the plurality of hierarchy or authorization levels according to the first data record that correspond to the manipulations to be enabled according to the second data record that are assigned to a currently used drug or a currently applied therapy.
However, Moskal et al teaches an authorization release selection device which is configured to assign at least one of the plurality of hierarchy or authorization levels to an operator as a function of an authorization certificate of the operator (col. 3, lines 1-10, “Role and Location Mapping mechanisms to assign permissions to users depending on their functional role”), and to enable only those manipulations assigned to the at least one of the plurality of hierarchy or authorization levels according to the first data record (col. 9, lines 25-30, “role database…role mapper”) that correspond to the manipulations to be enabled according to the second data record that are assigned to a currently used drug or a currently applied therapy (col. 5, lines 25-30, “user has pharmacist privileges at one location, he or she can only distribute a drug library to the pumps at that location for which he or she has authorization”).
It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to be motivated to combine the teachings of Moskal et al within the disclosure of Lee et al in order to provide the predictive result of improving determining role assigning on an individual basis for performing operations in a medical environment by assigning medical device access-level roles using location mapping (as disclosed in Abstract of Lee et al) because this feature allows for more distinct assigning to medical-related access privileges according to what role each operator is assigned to corresponding to the particular location the operator is currently located.
Regarding claim 2, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches an authentication device that is configured to determine an identity of the operator (par [0072] & par [0094], lines 1-4); and
a validation device that is configured to confirm the identity of the operator based on the data stored in the at least one data memory (par [0098], lines 1-5).
Regarding claim 3, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches an authenticating identifier configured to be assigned to the operator (par [0006], lines 1-5, “operator-unique identifiers are used as linked to authorization levels”).
Regarding claim 4, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches an authenticating identifier configured to be assigned to the operator wherein the authenticating identifier comprises a numeric code or an alphanumeric code (fig. 3).
Regarding claim 5, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the authenticating identifier comprises a biometric identifier (par [0071], lines 1-3).
Regarding claim 6, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the authenticating identifier comprises an RFID identifier (par [0100], lines 1-3).
Regarding claim 7, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the authentication device comprises a reader for scanning the authenticating identifier (par [0052], lines 10-11).
Regarding claim 8, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the authentication device comprises an input device for manually entering the authenticating identifier (par [0019]).
Regarding claim 9, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the authentication device comprises a data receiver (par [0057], lines 7-8).
Regarding claim 10, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the authentication device and the validation device are connected to one another by a system-internal data communication line (par [0110], lines 10-15).
Regarding claim 11, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the authorization release selection device and the validation device are connected to each other by a system-internal data communication line (par [0110], lines 10-15).
Regarding claim 12, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the medical device is an intensive-care device (fig. 8 & par [0035]).
Regarding claim 13, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the intensive-care device is an infusion pump (fig. 8 & par [0035]).
Regarding claim 14, Lee et al and Moskal et al teach the limitations of claim 1.
Lee et al further teaches wherein the intensive-care device is a blood treatment machine (par [0056], lines 1-2).
Regarding claim 15, Lee et al teaches a method for granting identity-specific authorizations to operators for performing authorization-dependent manipulations on a medical device (par [0006], which discloses granting and controlling authorization for users operating medical pumps), the method comprising the steps of:
entering data into a first data store or data set, wherein the data identifies a plurality of operator groups or hierarchy levels to which different authorization levels are assigned (par [0007], lines 10-22, which discloses recording authorization levels corresponding to individuals operating the medical pumps), wherein each authorization level is assigned selectable or selected manipulations of the medical device (par [0060], lines 10-15, “each task 71 will be assigned to an authorization level indicating generally a class of individuals who are authorized to complete that task”),
entering data into a second data store or data set, wherein the data identifies a plurality of different drugs and/or therapies (par [0013], “drug dispense system database holding information about drugs to be dispensed”), to each of which selectable or selected manipulations to be activated are assigned or at least one of the different authorization levels in accordance with the first data store or data set (par [0013], “saline and nutrition solutions may provide a first subdivision of authorization levels, painkillers a second subdivision of authorization levels and chemotherapy agents of third subdivision of authorization levels”); and
assigning at least one of the hierarchy levels from the first data store or data set to an operator depending on credentials provided by the operator (par [0069-0070] & par [0072], which disclose user medical authorization levels being applied upon the user entering authentication-related data, such as password or biometric data).
Lee et al does not explicitly teach enabling manipulations contained in the at least one of the hierarchy levels that match the selectable or selected manipulations according to the second data store or data set.
However, Moskal et al teaches enabling manipulations contained in the at least one of the hierarchy levels that match the selectable or selected manipulations according to the second data store or data set (col. 5, lines 25-30, “user has pharmacist privileges at one location, he or she can only distribute a drug library to the pumps at that location for which he or she has authorization” & col. 9, lines 25-30, “role database…role mapper”).
It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to be motivated to combine the teachings of Moskal et al within the disclosure of Lee et al in order to provide the predictive result of improving determining role assigning on an individual basis for performing operations in a medical environment by assigning medical device access-level roles using location mapping (as disclosed in Abstract of Lee et al) because this feature allows for more distinct assigning to medical-related access privileges according to what role each operator is assigned to corresponding to the particular location the operator is currently located.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Randy A. Scott whose telephone number is (571) 272-3797. The examiner can normally be reached on Monday-Thursday 7:30 am-5:00 pm, second Fridays 7:30 am-4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Luu Pham can be reached on (571) 270-5002. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDY A SCOTT/Primary Examiner, Art Unit 2439 20260804
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