DETAILED ACTION
This action responds to Application No. 19/160678, filed 08/28/2025, and to the preliminary amendment filed therewith.
At this point, claims 1-15 have been amended, and are presented for examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/28/2025 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
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, 8-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al (US 7103667 B1) in view of Ledford et al 2016/0339167 A1).
Re claim 1, Bell discloses the following:
A method of operation of [data] on a server, wherein the server comprises a memory unit for storing data, comprising the steps of: (col. 10, line 36 to col. 11, line 15). The end user’s computer (server) comprises resources including memory and disk space (a memory unit for storing data);
creating at least one profile on the server, wherein creating the at least one profile comprises allocating in the memory unit a total amount of memory for the at least one profile; and (col. 10, line 36 to col. 11, line 15). A QoS policy utilizes a terminal profile (at least one profile) for an end user’s computer (server) which defines the available resources of the server, which includes free memory and disk space (allocating in the memory unit a total amount of memory for the at least one profile);
adding a current […] profile […] to the at least one profile, wherein the adding the current […] profile comprises determining a memory requirement of the current […] profile and determining a remaining amount of memory of the at least one profile, wherein the remaining amount of memory of the at least one profile depends on the memory requirement of the current […] profile (col. 10, line 36 to col. 11, line 15; col. 12, lines 45-61) The resources (including memory requirements) of the media profile (current file) is compared against the resources (remaining amount of memory) associated with the terminal profile for the QoS policy (at l east one profile); if there are sufficient available resources, then the stream profile is added to the list of viable streams for the QoS policy associated with the terminal profile (at least one profile). Whether there are sufficient available resources is determined based on comparing a remaining amount of memory to the amount required for the stream (current profile).
It is noted that no specific functionality of the “drug library” or “drug profile” are actually claimed; accordingly, while it would have been obvious that the profiles of Bell could be associated with any type of data, including “drug” data, in the interest of furthering compact prosecution, Examiner has provided Ledford.
Ledford discloses the following:
a drug library on a server (Fig. 5, server 520, drug libraries 510). The drug libraries are stored on a server;
adding a current drug profile of the drug library to the at least one profile (¶ 29). The drug profiles can be downloaded from the drug libraries and created or aggregated to (added) to be associated with an identifying feature (at least one profile)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the profile storage allocation of Bell such that storage is allocated for drug profiles, as in Ledford, because it would be applying a known technique to improve a known method ready for improvement to yield predictable results. Bell discloses a method of allocating memory for profiles based on the memory requirements of the profiles as well as the amount of remaining memory resources, which is ready for the improvement of the profiles being associated with drugs in a drug library. Ledford discloses associating drug profiles from a drug library to an identifying feature , which is applicable to the profile memory management of Bell. It would have been obvious to modify the profiles of Bell to be associated with drug profiles, as in Ledford, because it would yield the predictable improvement of ensuring that there is sufficient memory to store the drug profiles such that they can be present in the memory to perform their intended functionality.
Re claim 2, Bell and Ledford disclose the method of claim 1, and Bell further discloses that the remaining amount of memory of the at least one profile depends additionally on the total amount of memory for the at least one profile and a sum of memory requirements of […] profiles previously added to the at least one profile and the memory requirement of the current […] profile (col. 10, line 36 to col. 11, line 15). The remaining amount of memory of the profile is reduced each time a media profile is approved (added); accordingly, the remaining amount of memory is equal to the total amount of memory minus the amounts previously allocated for the media profiles, as well as the amount needed for the current media profile.
Ledford discloses that the profiles are drug profiles (¶ 29).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to combine Bell and Ledford, for the reasons noted in claim 1 above.
Re claim 3, Bell and Ledford disclose the method of claim 1, and Bell further discloses that a maximum number of storable […] profiles is determined dynamically based on the remaining amount of memory (col. 10, line 36 to col. 11, line 15). The system determines whether additional media profiles can be approved (maximum number of storable profiles) based on the remaining amount of memory; if there is no available memory, then the system must either terminate other media profiles or cancel pending requests; in either case, the system has determined a maximum number of profiles that may be stored.
Ledford discloses that the profiles are drug profiles (¶ 29).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to combine Bell and Ledford, for the reasons noted in claim 1 above.
Re claim 8, Bell and Ledford disclose the method of claim 1, and Ledford further discloses the step of creating a current drug profile in the drug library, wherein the step of creating the current drug profile comprises receiving drug data through user input (¶ 9). A user may create a drug profile, and may upload it to the server and a corresponding databased of other delivery files (drug library) by interacting with a user interface (through user input).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to combine Bell and Ledford, for the reasons noted in claim 1 above.
Re claim 9, Bell and Ledford disclose the method of claim 1, and Ledford further discloses the step of generating a dataset, wherein the dataset comprises the at least one profile (¶ 29). The infusion profiles or segments of profiles may be aggregated into databases or libraries (generating a dataset).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the memory storage method of Bell to aggregate profiles to generate a dataset, as in Ledford, because Ledford suggests that doing so would allow a set of profiles to be associated with an identifying feature (¶ 29).
Re claim 10, Bell Ledford disclose the method of claim 9, and Ledford further discloses the step of uploading the dataset to an infusion, wherein the uploading the dataset to the infusion device comprises pushing, by the server, the dataset to the infusion device or pulling, by the infusion device, the dataset from the server (¶ 29 and 34). The databases or libraries of profiles (dataset) may be uploaded between devices, including infusion devices and servers (¶ 29). The transfers are initiated (pulled) by a user at the infusion pump (¶ 34).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to combine Bell and Ledford, for the reasons noted in claim 9 above.
Re claim 11, Bell and Ledford disclose the method of claim 10, and Ledford further discloses that the uploading the dataset to the infusion device comprises transmitting dedicated commands to the infusion device (¶ 34). The uploading comprises transmitting an initiate instruction (dedicated command) to the infusion device.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to combine Bell and Ledford, for the reasons noted in claim 9 above.
Re claim 14, Bell and Ledford disclose the method of claim 1, and Ledford further discloses A server for operation of a drug library, wherein the server comprises processing circuitry configured to execute that method (¶ 29). The profile library is managed by a server, which is a computer, and computers contain processors.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to combine Bell and Ledford, for the reasons noted in claim 1 above.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bell in view of Ledford, further in view of Doak et al (US 2003/0058238 A1).
Re claim 4, Bell and Ledford disclose the method of claim 1, but do not specifically disclose displaying a memory progress bar to a user.
Doak discloses that the remaining amount of memory is output to a user via a progress bar (Fig. 6D, free memory indicator 666; ¶ 144). The free memory indicator, which indicates an amount of free (remaining) memory, is displayed to a user via a bar graph (progress bar).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the memory allocation system of Bell (combined with Ledford) to output the amount of remaining memory to a user, as in Doak, because Doak suggests that displaying the memory indicator would assist the user in making decisions about which resources to allocate (¶ 144).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bell in view of Ledford, further in view of Doak, and further in view of Sexton (US 2022/0133292 A1).
Re claim 5, Bell, Ledford, and Doak disclose the method of claim 4, but do not specifically disclose a prompt to confirm an addition of the current drug profile.
Sexton discloses that the output comprises a prompt to confirm an addition of the current drug profile to the at least one profile (Figs. 10-11; ¶ 8 and 67-68). The patient may add a drug to their drug profile, and is prompted (output) to confirm the changes.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the drug profile allocation of Ledford (combined with Bell and Doak) to confirm changes to a drug profile, as in Sexton, because Sexton suggests that this would be a way to edit the drug profile securely, for added security (¶ 68-69).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Bell in view of Ledford, further in view of O’Connell (US 6678788 B1).
Re claim 6, Bell and Ledford disclose the method of claim 1, and Ledford further discloses drug profiles (¶ 12). See claim 1 above.
However, Bell and Ledford do not specifically disclose a weight classification scheme.
O’Connell discloses that the adding the current [data] comprises determining a weight of the current [data], wherein the weight of the current [data] depends on the memory requirements of the current [data] and a weight classification scheme (¶ 36, line 49 to col. 37, line 3). The data items to be written are classified into different classifications based on, among other things, size requirements of the data; this is a “weight classification scheme”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the allocation of Bell (combined with Ledford) to classify data by size requirements, as in O’Connell, because O’Connell suggests that this would allow for grouping data by classification to improve efficient memory operation (col. 40, line 66 to col. 41, line 17).
Re claim 7, Bell, Ledford, and O’Connell disclose the method of claim 6, and Ledford further discloses drug profiles (¶ 29). See claim 1 above.
O’Connell further discloses that the weight classification scheme comprises a number of weights, wherein each weight is associated with a memory interval and the current [data] is assigned the weight associated with the memory interval into which the memory requirement of the current [data] falls (¶ 36, line 49 to col. 37, line 3). The data items are classified into a number of different classifications (weights), each associated with a different size (memory requirements of the current data).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to combine Bell, Ledford, and O’Connell, for the reasons noted in claim 6 above.
Claims 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ledford in view of Golov (US 2022/0365718 A1).
Re claim 12, Ledford discloses the following:
A method of operation on an infusion device comprising a memory unit for storing data, wherein the method comprises the steps of: (Fig. 2). Infusion pump 210 (infusion device) contains a memory 255 for storing data;
downloading a dataset from a server, wherein the dataset comprises at least one profile, wherein the at least one profile comprises at least one drug profile, wherein the at least one drug profile comprises drug data (Figs. 6-7). The infusion pump connects to a central server and downloads a predetermined profile or profiles (dataset comprising at least one drug profile containing drug data;
storing the dataset to the infusion device, wherein the storing the dataset to the infusion device comprises […] storing the at least one drug profile of the at least one profile in the memory unit of the infusion device (¶ 33). The profiles (dataset) can be stored to the memory of the infusion device.
Ledford does not explicitly disclose storing the profiles “contiguously”.
Golov discloses contiguously storing the at least one […] profile of the at least one profile in the memory unit (¶ 59). In some embodiments, profile storage address space is contiguous.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the infusion device profile storage method of Ledford to store profiles in a contiguous storage address space, as in Golov, because it would be applying a known technique to a known method ready for improvement, to yield predictable results. Ledford discloses storing profile data in the memory of an infusion device, which is ready for the improvement of storing profile data contiguously. Golov discloses storing profile data in a contiguous storage address space, which is applicable to the profile storage of Ledford. It would have been obvious to modify the profile storage of Ledford to store it contiguously, as in Golov, because it would yield the predictable result that the profile data would be located in the same location, thus improving data locality and allowing the data to be retrieved from the same location.
Re claim 15, Ledford and Golov disclose the method of claim 12, and Ledford further discloses that the infusion device comprises processing circuitry configured to execute that method (Fig. 2, processor 250). The processor of the infusion pump (infusion device) executes the described method.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ledford in view of Golov, further in view of Ali et al (US 2015/0133888 A1).
Re claim 13, Ledford and Golov disclose the method of claim 12, but do not specifically disclose a cyclic redundancy check.
Ali discloses that the storing the profile to the infusion device comprises adding cyclic redundancy checks for drug data (¶ 156). Drug delivery schedules (profiles) received at the drug delivery device (infusion device) are checked for errors using cyclic redundancy checks.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the drug infusion device profile storage of Ledford (combined with Golov) to check for errors using a cyclic redundancy check, as in Ali, because Ali suggests that doing so would allow the system to detect and correct errors in order to resume safe delivery of drugs to the patient (¶ 156).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Martinez et al (US 2006/0229551 A1) – discloses an infusion device which associates drug profiles from a drug library with particular patient IDs (¶ 50).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG S GOLDSCHMIDT whose telephone number is (571)270-3489. The examiner can normally be reached M-F 10-6.
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/CRAIG S GOLDSCHMIDT/Primary Examiner, Art Unit 2132
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