DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to an application filed on 02/07/2024. Claims 1-16 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 recites “A non-transitory computer readable medium storing a software program comprising data and computer implementable instructions for carrying out the method of claim 15 “. When, as here, an independent claim recites a particular method, a dependent claim drawn to a computer-readable medium capable of performing the method of the independent claim is not a proper dependent claim, since the dependent claim could conceivably be infringed by mere possession of the computer program on a computer-readable medium without performing any particular method steps at all, thereby infringing the dependent claim without necessarily infringing the independent claim, in violation of the infringement test for proper dependency of claims. See MPEP § 608.01(n)(III). Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept — i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
STEP 1
The claims are directed to a system and method which is included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims recite the abstract idea (based on claim 15) of:
A method for automated monitoring of extracorporeal support patient care, comprising: receive user selection of an operating mode for treatment of a patient supported with an extracorporeal support device; retrieving a checklist associated with the operating mode selected, the checklist comprising a plurality of action items required to be performed by a medical staff in treatment of the patient at a predetermined synchronized manner; presenting the plurality of action items in accordance with the predetermined synchronized manner for prompting user confirmation of performing a respective portion of the plurality of action items presented at a respective timepoint; and outputting an alert in response to not receiving user confirmation within a predetermined timeout.
The claims, as illustrated by the limitations of Claim 1 above, recite an abstract idea within the “certain methods of organizing human activity” grouping — managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
The claims recite alerting not receiving user confirmation of performance of action items from a presented checklist of action items that are retrieved from a database after a user selects an operating mode. Alerting not receiving user confirmation of performance of action items from a presented checklist of action items that are retrieved from a database after a user selects an operating mode is a process that merely organizes human activity, as it involves following rules and instructions to receive user selection of an operating mode, retrieving a checklist, presenting action items from the checklist, and outputting an alert. It also involves an interaction between a person and a computer. Interaction between a person and computer qualifies as interaction under certain methods of organizing human activity. See MPEP 2106.04(a)(2)(II). As such, the claims recite an abstract idea within the categories of certain methods of organizing human activity.
The dependent claims 3-8, 10, 12, and 14 recite further abstract ideas within the category of certain methods of organizing human activity, such as 3 the checklist comprising at least one subset of the plurality of action items which members thereof are sequentially ordered, wherein presenting members of a respective one of the at least one subset in a respective sequential order; 4 presenting a subsequent action item of a respective one of the at least one subset is contingent on receiving user confirmation of performing an action item presented; 5 at least one of said plurality of action items is associated with a timer, wherein suspending of prompting user confirmation until expiry of the timer of the respective action item; wherein outputting user notification in response to expiry of the timer; 7 wherein providing an indication of user progress on the checklist; 8 wherein overlaying the indication of user progress on an output provided; 10 wherein recording information relating to user execution of the checklist; 12 wherein loading the checklist from a user input received; 14 wherein the operating mode having a mode transition checklist associated therewith, the mode transition checklist comprising another plurality of action items on which switching to the operating mode is preconditioned, wherein retrieving the mode transition checklist, presenting the another plurality of action items for prompting user confirmation of performing thereof, and outputting an alert in response to not receiving user confirmation within a predetermined timeout.
STEP 2A PRONG TWO
The claims recite additional elements beyond those that encompass the abstract idea above including:
Independent claim 1:
a processing circuitry adapted to execute a code for:
providing an interactive user interface adapted to
from a database
via the interactive user interface
Dependent claim 2:
the interactive user interface is provided via an integrated man-machine interface of the extracorporeal support device
Dependent claim 3:
the processing circuitry is further adapted to execute a code for
Dependent claim 5:
the processing circuitry is further adapted to execute a code for
Dependent claim 6:
the processing circuitry is further adapted to execute a code for
Independent claim 7:
the processing circuitry is further adapted to execute a code for
via the interactive user interface
Dependent claim 8:
the processing circuitry is further adapted to execute a code for
via another user interface of the extracorporeal support device
Dependent claim 10:
the processing circuitry is further adapted to execute a code for
in at least one data store
Dependent claim 11:
the at least one data store
electronic
Dependent claim 12:
the processing circuitry is further adapted to execute a code for
Dependent claim 14:
the processing circuitry is further adapted to execute a code for:
from the database
via the interactive user interface
Dependent claim 15:
providing an interactive user interface adapted to
from a database
via the interactive user interface
Dependent claim 16:
A non-transitory computer readable medium storing a software program comprising data and computer implementable instructions for carrying out the method of claim 15
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with considerations laid out by the Supreme Court or the Federal Circuit. (see MPEP 2106.05 a-c and e) The additional elements integrate the abstract idea into a practical application when they: improve the functioning of a computer or improving any other technology, apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, apply the judicial exception with, or by use of, a particular machine, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. The additional limitations do not integrate the abstract idea into a practical application when they merely serve to link the use of the abstract idea to a particular technological environment or field of use — i.e. merely uses the computer as a tool to perform the abstract idea; or recite insignificant extra-solution activity (see MPEP 2106.05 f - h).
The processing circuitry, interactive user interface, database, data store, and computer-readable medium are recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using generic computer components. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment. Nothing in the claim recites specific limitations directed to an improved processing circuitry, interactive user interface, database, data store, and computer-readable medium. Similarly, the specification is silent with respect to these kinds of improvements. A general purpose computer that applies a judicial exception to computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a basic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claims do not integrate the abstract extracorporeal support process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract extracorporeal support process. The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting basic computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently straightforward such that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination, the limitations recited in the claims add nothing that is not already present when the steps are considered individually.
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. For example, dependent claim limitations 3 the checklist comprising at least one subset of the plurality of action items which members thereof are sequentially ordered, wherein presenting members of a respective one of the at least one subset in a respective sequential order; 4 presenting a subsequent action item of a respective one of the at least one subset is contingent on receiving user confirmation of performing an action item presented; 5 at least one of said plurality of action items is associated with a timer, wherein suspending of prompting user confirmation until expiry of the timer of the respective action item; wherein outputting user notification in response to expiry of the timer; 7 wherein providing an indication of user progress on the checklist; 8 wherein overlaying the indication of user progress on an output provided; 10 wherein recording information relating to user execution of the checklist; 12 wherein loading the checklist from a user input received; 14 wherein the operating mode having a mode transition checklist associated therewith, the mode transition checklist comprising another plurality of action items on which switching to the operating mode is preconditioned, wherein retrieving the mode transition checklist, presenting the another plurality of action items for prompting user confirmation of performing thereof, and outputting an alert in response to not receiving user confirmation within a predetermined timeout are directed to the abstract idea of certain methods of organizing human activity without integrating into a practical application or amounting to significantly more. Dependent claim limitations 2 the interactive user interface is provided via an integrated man-machine interface of the extracorporeal support device; 9 the operating mode is selected from the group consisting of: medical staff shift change, supported patient transportation, patient support initiation, and supported patient weaning; 11 wherein the at least one data store comprising an electronic medical record; 13 wherein the user input is provided in a tabular data format; 16 A non-transitory computer readable medium storing a software program comprising data and computer implementable instructions for carrying out the method of claim 15 merely serve to further narrow the abstract idea above. As such, the additional elements do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention. Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Curtis, et al. (US 2012/0138533 A1) in view of Gupta, et al. (US 2019/0034592 A1).
With regards to claim 1, Curtis teaches a system for automated monitoring of extracorporeal support patient care, comprising: a processing circuitry adapted to execute a code for: providing an interactive user interface adapted to receive user selection of an operating mode for treatment of a patient supported with an extracorporeal support device (see at least figure 5, ¶ 0103, user can be presented with a welcome screen by the user interface 110 on a visual presentation device 415. In some cases, the visual presentation device 415 is a touch screen. This welcome screen presents the user with information and options. The information on the welcome screen can include scheduled maintenance 520, such as disinfection due date and filter lifetime. Options the user has can include editing the prescribed hemodialysis treatment 515, editing the patient information 515, viewing and editing preferences 510, and beginning dialysis 505.); retrieving from a database a checklist associated with the operating mode selected, the checklist comprising a plurality of action items required to be performed by a medical staff in treatment of the patient… (see at least figure 6, ¶ 0104, when the user selects to begin dialysis, the user interface 110 can begin to visually present the steps of the start-up procedure (“Pre-Treatment Setup”) to the user); presenting via the interactive user interface the plurality of action items …for prompting user confirmation of performing a respective portion of the plurality of action items presented at a respective timepoint (see at least figure 6, ¶ 0104, presenting treatment steps and prompting user to select “OK” to confirm steps have been completed at a particular time)
Curtis does not explicitly teach …at a set of time intervals; …in accordance with the set of time intervals…; and outputting an alert in response to not receiving user confirmation within a predetermined timeout. Gupta teaches …at a set of time intervals; …in accordance with the set of time intervals…; and outputting an alert in response to not receiving user confirmation within a predetermined timeout (see at least ¶ 0019, treatment actions have predetermined time limits [time intervals]; ¶ 0055, if countdown timer for action item expires before the user confirmation is made, the system generates an alert). It would have been obvious to one of ordinary skill in the art to combine the treatment action item time intervals of Gupta with the dialysis treatment step display system of Curtis with the motivation of optimization of patient treatment (Gupta, ¶ 0001-0002).
Claim 15 recites similar limitations regarding the method of the system and is rejected for the same reasons.
With regards to claim 2, Curtis teaches the system of claim 1, wherein the interactive user interface is provided via an integrated man-machine interface of the extracorporeal support device (see at least figures 1, 4).
With regards to claim 3, Curtis teaches the system of claim 1, wherein the checklist comprising at least one subset of the plurality of action items which members thereof are sequentially ordered, wherein the processing circuitry is further adapted to execute a code for presenting members of a respective one of the at least one subset in a respective sequential order (see at least figures 5-32, pre-treatment, treatment, and post-treatment steps are provided in sequential order).
With regards to claim 4, Curtis teaches the system of claim 3, wherein presenting a subsequent action item of a respective one of the at least one subset is contingent on receiving user confirmation of performing an action item presented (see at least figures 5-32, once treatment step is completed and a button on screen is clicked to indicate completion confirmation, user interface is changed to next screen with next action item(s)).
With regards to claim 5, Gupta teaches the system of claim 1, wherein at least one of said plurality of action items is associated with a timer, wherein the processing circuitry is further adapted to execute a code for suspending of prompting user confirmation until expiry of the timer of the respective action item (see at least figure 2 (316), ¶ 0053, the system displays the action item on one or more of the user devices 106, 108, 110 and at step 316 the system sets a countdown timer for one of the members of the medical team to complete the identified action item within a target timeframe). It would have been obvious to one of ordinary skill in the art to combine the treatment action item time intervals of Gupta with the dialysis treatment step display system of Curtis with the motivation of optimization of patient treatment (Gupta, ¶ 0001-0002).
With regards to claim 6, Gupta teaches the system of claim 5, wherein the processing circuitry is further adapted to execute a code for outputting user notification in response to expiry of the timer (see at least ¶ 0055, If the countdown timer expires before the user confirmation is made, the system 100 generates an alert as shown at step 322. The alert may be sent the management devices 112 and/or administrator devices 112, 114 in the system 100. Real time identification of the missed timeline for completing an action item is made to the appropriate persons so that corrective actions may be taken. The alert may be delivered in any form desired, including but not limited to phone calls, SMS text messages, push notifications, email messages, facsimiles, etc. Other optional steps taken by the system 100 may including highlighting the action items on the user devices 106, 108, 110, presenting message pop-ups or windows on the user devices 106, 108, 110 and setting another countdown timer for completion of the action item. Escalating alerts may be sent to different devices and persons if the action item is not timely resolved.). It would have been obvious to one of ordinary skill in the art to combine the treatment action item time intervals of Gupta with the dialysis treatment step display system of Curtis with the motivation of optimization of patient treatment (Gupta, ¶ 0001-0002).
With regards to claim 7, Curtis teaches the system of claim 1, wherein the processing circuitry is further adapted to execute a code for providing via the interactive user interface an indication of user progress on the checklist (see at least figures 5-19, 25-32, ¶ 0120, progress bar at bottom of user interface display shows user progress on pre-treatment and post-treatment steps).
With regards to claim 8, Curtis teaches the system of claim 7, wherein the processing circuitry is further adapted to execute a code for overlaying the indication of user progress on an output provided via …user interface of the extracorporeal support device (see at least figures 5-19, 25-32, ¶ 0120, progress bar at bottom of user interface display shows user progress on pre-treatment and post-treatment steps).
Additionally, Gupta teach …another (see at least ¶ 0055, multiple devices). It would have been obvious to one of ordinary skill in the art to combine the treatment action item time intervals of Gupta with the dialysis treatment step display system of Curtis with the motivation of optimization of patient treatment (Gupta, ¶ 0001-0002).
With regards to claim 9, Curtis teaches the system of claim 1, wherein the operating mode is selected from the group consisting of: medical staff shift change, supported patient transportation, patient support initiation, and supported patient weaning (see at least figure 6, ¶ 0104, start-up procedure (“Pre-Treatment Setup”) [patient support initiation]).
With regards to claim 10, Curtis teaches the system of claim 1, wherein the processing circuitry is further adapted to execute a code for recording information relating to user execution of the checklist in at least one data store (see at least ¶ 0052, user interface communicates with patient monitoring system [data store] which receives information regarding patient’s status or condition before, during, and/or after dialysis [information related to user execution of the checklist]).
With regards to claim 11, Curtis teaches the system of claim 10, wherein the at least one data store comprising an electronic medical record (see at least figure 4, ¶ 0052).
With regards to claim 12, Curtis teaches the system of claim 1, wherein processing circuitry is further adapted to execute a code for loading the checklist from a user input received (see at least figures 5-6, ¶ 0104, when the user selects to begin dialysis, the user interface 110 can begin to visually present the steps of the start-up procedure (“Pre-Treatment Setup”) to the user).
With regards to claim 13, Curtis teaches the system of claim 12, wherein the user input is provided in a tabular data format (see at least figures 5-6).
With regards to claim 14, Curtis teaches the operating mode having a mode transition checklist associated therewith, the mode transition checklist comprising another plurality of action items on which switching to the operating mode is preconditioned, wherein the processing circuitry is further adapted to execute a code for: retrieving from the database the mode transition checklist, presenting via the interactive user interface the another plurality of action items for prompting user confirmation of performing thereof (see at least figures 5-32, system has a checklist for pre-treatment setup, a checklist of elements to enter during treatment, and a checklist for post-treatment [mode transitions].
Gupta teaches … and outputting an alert in response to not receiving user confirmation within a predetermined timeout. (see at least ¶ 0055, if countdown timer for action item expires before the user confirmation is made, the system generates an alert). It would have been obvious to one of ordinary skill in the art to combine the treatment action item time intervals of Gupta with the dialysis treatment step display system of Curtis with the motivation of optimization of patient treatment (Gupta, ¶ 0001-0002).
With regards to claim 16, Curtis teaches the non-transitory computer readable medium storing a software program comprising data and computer implementable instructions for carrying out the method of claim 15 (see at least ¶ 0075, software).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gassman (US 2023/0032772 A1) which discloses medical fluid delivery system and apparatus for remote machine updating and control are disclosed. An example medical fluid delivery apparatus includes a processor and a dialysis fluid circuit including at least one dialysis fluid pump. Th processor is configured to receive a disinfection input to begin a disinfection procedure and cause the at least one dialysis fluid pump to perform a disinfection procedure on the dialysis fluid circuit using a disinfection fluid. The processor is also configured to, after the disinfection procedure is complete, start a disinfection timer. When a dialysis input is received before the disinfection timer reaches zero, the processor enables a dialysis treatment to be performed. When the disinfection timer reaches zero before the dialysis input is received, the processor prevents the dialysis treatment from being performed until the disinfection procedure is performed again.
Adi (US 2023/0274659 A1) which discloses a dialysis path includes dialysis steps such as a machine interaction step. A machine state input receives dialysis machine status information for a dialysis machine. An instruction output provides instructional information for a dialysis procedure for a patient. A dialysis process state is used to identify completion of the dialysis steps. A user performing the dialysis steps in a proper order causes the dialysis process state to traverse the dialysis path of a dialysis procedure, beginning at a first dialysis step and ending at a last dialysis step. The machine interaction step includes a user interaction with the dialysis machine that causes the dialysis machine status information, changes the dialysis process state, and completes the machine interaction step. Current step information in the instructional information guides the user to completing a current step. The instruction output provides the current step information to the user.
Silver SA, Thomas A, Rathe A, Robinson P, Wald R, Harel Z, Bell CM. Development of a hemodialysis safety checklist using a structured panel process. Can J Kidney Health Dis. 2015 Feb 12;2:5. doi: 10.1186/s40697-015-0039-8. PMID: 25780628; PMCID: PMC4349476 which discloses a novel 17-item Hemodialysis Safety Checklist (Hemo Pause) for use by nurses and patients has been developed to standardize the hemodialysis procedure. Further quality improvement efforts are underway to explore the feasibility of using this checklist to reduce adverse events and strengthen the safety culture in the hemodialysis unit.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joey Burgess whose telephone number is (571)270-5547. The examiner can normally be reached Monday through Friday 9-6.
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/JOSEPH D BURGESS/ Primary Examiner, Art Unit 3685
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