DETAILED ACTION
Notice to Applicant
The present application is being examined under the pre-AIA first to invent provisions.
This action is in reply to the filed on 6/28/2024.
Claims 2-21 currently pending and have been examined.
Priority
Applicant’s claim for the benefit of prior-filed applications (provisional application 61/793,620, filed 3/15/2013, non-provisional application 14/774,336, filed 9/10/2015) under 35 U.S.C. 110(e) or under 35 U.S.C. 120, 121, or 365(c), or under 35 U.S.C. 119(a)-(d) or (f) is acknowledged.
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.
Human Interactions Organized
Applicant discloses (Applicant’s Specification, [0005]) that there is a need to provide useful status information to users during extracorporeal blood treatment. So a need exists to organize these human interactions by/through displaying status information using the steps of “removing blood, pumping blood and dialysate fluids, removing effluent, adding replacement fluid, returning blood, determining next reservoir changes, displaying graphical user interfaces, displaying next reservoir changes,” etc. Applicant’s system/method is therefore a certain method of organizing the human activities as described and disclosed by Applicant.
Rejection
Claim(s) 2-21 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1 and 13 is/are directed to the abstract idea of “displaying status information,” etc. (Applicant’s Specification, Abstract, paragraph(s) [0002]), etc., as explained in detail below, and thus grouped as a certain method of organizing human interactions. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea. Accordingly, claims 2-21 recite an abstract idea.
Step 2A Prong 1 – The Judicial Exception
The claim(s) recite(s) in part, system/method for performing the steps of “removing blood, pumping blood and dialysate fluids, removing effluent, adding replacement fluid, returning blood, determining next reservoir changes, displaying graphical user interfaces, displaying next reservoir changes,” etc., that is “displaying status information,” etc. which is a method of managing personal behavior or relationships or interactions between people (social activities, teaching, following rules, instructions) and thus grouped as a certain method of organizing human interactions. Accordingly, claims 2-21 recite an abstract idea.
Step 2A Prong 2 – Integration of the Judicial Exception into a Practical Application
This judicial exception is not integrated into a practical application because the generically recited additional computer elements (i.e. input apparatus, display apparatus, treatment apparatus, graphical user interface (Applicant’s Specification [0018]-[0019]), etc.) to perform steps of “removing blood, pumping blood and dialysate fluids, removing effluent, adding replacement fluid, returning blood, determining next reservoir changes, displaying graphical user interfaces, displaying next reservoir changes,” etc. do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and this is nothing more than an attempt to generally link the product of nature to a particular technological environment. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limit on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Insignificant extra-solution activity
Claim(s) 2-21 recites storing data steps, retrieving data steps, providing data steps, output steps (Bilski v. Kappos, 561 U.S. 593, 610-12 (2010), Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can., 771 F.Supp.2d 1054, 1066 (E.D. Mo. 2011), aff’d, 687 F.3d at 1266), and/or transmitting data step (buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014), Apple, Inc. v. Ameranth, Inc., 842 F.3d 1299, 1241-42 (Fed. Cir. 2016)) that is/are insignificant extra-solution activity. Extra-solution activity limitations are insufficient to transform judicially excepted subject matter into a patent-eligible application (MPEP §2106.05(g)).
Step 2B – Search for an Inventive Concept/Significantly More
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements (i.e. input apparatus, display apparatus, treatment apparatus, graphical user interface, etc.) are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept (Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”)). Accordingly, the claims are not patent eligible.
Individually and in Combination
The additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The additional elements amount to no more than generic computer components that serve to merely link the abstract idea to a particular technological environment (i.e. input apparatus, display apparatus, treatment apparatus, graphical user interface, etc.). At paragraph(s) [0018]-[0019], Applicant’s specification describes generic computer hardware for implementing the above described functions including “input apparatus, display apparatus, treatment apparatus, graphical user interface,” etc. to perform the functions of “removing blood, pumping blood and dialysate fluids, removing effluent, adding replacement fluid, returning blood, determining next reservoir changes, displaying graphical user interfaces, displaying next reservoir changes,” etc. The recited “input apparatus, display apparatus, treatment apparatus, graphical user interface,” etc. does/do not add meaningful limitations to the idea of beyond generally linking the system to a particular technological environment, that is, implementation via computers. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, or improves any other technology, or improves a technical field, or provides a technical improvement to a technical problem. Their collective functions merely provide generic computer implementation. Therefore, claims 2-21 do not amount to significantly more than the underlying abstract idea of “an idea of itself” (Alice).
Dependent Claims
Dependent claim(s) 3-12 and 14-21 include(s) all the limitations of the parent claims and are directed to the same abstract idea as discussed above and incorporated herein.
Although dependent claims 3-12 and 14-21 add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. Dependent claims 3-12 and 14-21 merely describe physical structures to implement the abstract idea. These information and physical characteristics do not change the fundamental analogy to the abstract idea grouping of certain method of organizing human interactions, and when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as independent claim(s) 1 and 13.
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(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 2-21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rankers et al. 572 (US 2008/0300752), in view of Rankers et al. 330 (US 2010/0010330).
CLAIM 2
As per claim 2, Rankers et al. 572 disclose:
a method (Rankers et al. 572, [0007] method) of extracorporeal blood treatment comprising:
maintaining a plurality of reservoirs comprising an effluent reservoir, a dialysate reservoir, and replacement fluid reservoir (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).;
removing blood from a patient (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]);
pumping the blood through a treatment set and dialysis filter (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]);
pumping dialysate fluid from the dialysate reservoir through the dialysis filter (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]);
removing effluent from the blood using the dialysis filter into an effluent reservoir (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]);
adding replacement fluid from the replacement fluid reservoir to the patient's blood in the treatment set (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]);
returning the blood to the patient via the treatment set following the dialysis filter (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]);
displaying on a graphical user interface a fluid region comprising a plurality of fluid areas corresponding to at least each of the plurality of reservoirs, wherein at least one fluid area of the plurality fluid areas comprises a pump element and a reservoir element, wherein the pump element defines a flow rate of the fluid during performance of the extracorporeal blood treatment and the reservoir element comprises a fluid level representative of an amount of the fluid within the reservoir storing the fluid during performance of the extracorporeal blood treatment (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
Rankers et al. 572 fail to expressly disclose:
determining which of the plurality of reservoirs is next to require a reservoir change to maintain performance of the extracorporeal blood treatment
displaying a next reservoir change notification proximate a fluid area of the plurality of fluid areas corresponding to the determined reservoir of the plurality of reservoirs that is next to require a reservoir change to indicate that the fluid within the determined reservoir is the next reservoir that requires a reservoir change to maintain performance of the extracorporeal blood treatment.
However, Rankers et al. 330 teach:
determining which of the plurality of reservoirs is next to require a reservoir change to maintain performance of the extracorporeal blood treatment (Rankers et al. 330, Figure 1, Figure 3, Figure 4, Figure 5, Figure 6 502 Pump status data, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 15, Figure 16, Figure 19 806 Generate pump reservoir icon with remaining time indicator, 822 Generate and display an alarm screen, [0012]-[0032], [0037] fluid infusion system 100, [0038]-[0064])
displaying a next reservoir change notification proximate a fluid area of the plurality of fluid areas corresponding to the determined reservoir of the plurality of reservoirs that is next to require a reservoir change to indicate that the fluid within the determined reservoir is the next reservoir that requires a reservoir change to maintain performance of the extracorporeal blood treatment (Rankers et al. 330, Figure 1, Figure 3, Figure 4, Figure 5, Figure 6 502 Pump status data, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 15, Figure 16, Figure 19 806 Generate pump reservoir icon with remaining time indicator, 822 Generate and display an alarm screen, [0012]-[0032], [0037] fluid infusion system 100, [0038]-[0064]).
One of ordinary skill in the art at the time the invention was made would have found it obvious to include “determining which of the plurality of reservoirs is next to require a reservoir change to maintain performance of the extracorporeal blood treatment,” etc. as taught by Rankers et al. 330 within the method as taught by the Rankers et al. 572 with the motivation of providing status information generated by one or more devices within an infusion system (Rankers et al. 330, [0002]).
CLAIM 3
As per claim 3, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein the next reservoir change notification comprises a time period representing an amount of time left before the reservoir change is required to maintain performance of the extracorporeal blood treatment (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
CLAIM 4
As per claim 4, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein the plurality of fluid areas further corresponds to one or more of pre blood pump, citrate, blood flow rate, patient fluid removal, anticoagulation, patient plasma loss, and calcium (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
CLAIM 5
As per claim 5, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein the reservoir element comprises a graphical depiction of a fluid stored in a fluid bag, and wherein the fluid level representative of the amount of fluid within the reservoir is defined by the level of fluid graphically depicted in the fluid bag (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
CLAIM 6
As per claim 6, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein the method further comprises: displaying on the graphical user interface a change region; allowing a user to select the change region to initiate one of a flow rate change and a bag change; and displaying a time period representing an amount of time left before the reservoir change is required proximate each of the plurality of fluid areas (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
CLAIM 7
As per claim 7, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein each fluid area of the plurality of fluid areas comprises a fluid connection extending between the pump element and the reservoir element (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
CLAIM 8
As per claim 8, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein the method further comprises: displaying a stop notification proximate a fluid area of the plurality fluid areas when a pump for the fluid is paused; and dismissing the stop notification if the pump resumes operation (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
CLAIM 9
As per claim 9, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein the method further comprises: displaying a changing reservoir notification proximate a fluid area of the plurality of fluid areas when a reservoir for the fluid is being changed; and dismissing the changing reservoir notification if the reservoir is removed (Rankers et al. 330, Figure 1, Figure 3, Figure 4, Figure 5, Figure 6 502 Pump status data, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 15, Figure 16, Figure 19 806 Generate pump reservoir icon with remaining time indicator, 822 Generate and display an alarm screen, [0012]-[0032], [0037] fluid infusion system 100, [0038]-[0064]).
The obviousness of combining the teachings of Rankers et al. 330 with the method as taught by Rankers et al. 572 is discussed in the rejection of claim 2, and incorporated herein.
CLAIM 10
As per claim 10, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein the method further comprises: displaying a calibration notification proximate a fluid area of the plurality of fluid areas when a reservoir for the fluid is being calibrated; and dismissing the calibration notification if the reservoir is finished being calibrated and ready for use (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
CLAIM 11
As per claim 11, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein the method further comprises: weighing each of the plurality of the reservoirs using a respective reservoir scale of a plurality of reservoir scales operably attached to the plurality of reservoirs, wherein each fluid area of the plurality of fluid areas is representative of a pump of the one or more pumps configured to pump the fluid represented by the fluid area and one reservoir scale of the plurality of reservoir scales configured to weigh the fluid (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
CLAIM 12
As per claim 12, Rankers et al. 572 and Rankers et al. 330
teach the method of claim 2 and further disclose the limitations of:
wherein the method further comprises displaying a reservoir status proximate each of the plurality of reservoirs using a plurality of reservoir status lights, wherein each reservoir status light of the plurality of reservoir status lights is associated with and proximate to one reservoir of the plurality of reservoirs (Rankers et al. 572, Figure 1, Figure 2, Figure 4, Figure 5 402 Configurable alarm logic, Figure 6, Figure 7, Figure 8, Figure 9, Figure 10, Figure 11, Figure 13, Figure 16, Figure 19, Figure 20, [0001], [0012]-[0031], [0036] fluid infusion system 100, [0037]-[0064]).
CLAIMS 13-21
As per claims 13-21, claims 13-21 are directed to a system. Claims 13-21 recite the same or similar limitations as those addressed above for claims 2-12. Claims 13-21 are therefore rejected for the same reasons set forth above for claims 2-12.
Prior Art
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO-892 and include:
Kollar et al. (US 2008/0027368) disclose a disposable cartridge for use in extracorporeal blood perfusions systems that have a control unit for controlling the flow of fluids.
Kamen et al. (US 2012/0185267) disclose a system for electronic patient care includes a hub. The hub is configured to monitor a patient-care device. The sandbox may be configured to control access to at least one of a hardware resource and a software resource. The hub is further configured to identify the patient-care device and execute an application to monitor the patient-care device.
Morales et al. 2001 (Reference U) disclose an intelligent Continuous VenoVenous Hemofiltration (CVVH) system that deals with accuracy and cost issues while improving the care delivered by timely responding to changes in a patient’s cardiovascular state. The intelligence aspect of the system is achieved through a hierarchical control architecture for CVVH. The control methodology uses a direct adaptive control scheme for the peristaltic pumps and a supervisory control algorithm for high-level decisions on the safe operation of the system.
Zhilo et al. (Reference V) disclose describes the general principles used in the development of the Renart-PD wearable artificial kidney apparatus and its control system. When developing such equipment, an important component is a detailed study of the control system, which includes subsystems for low-level control of the hardware, protection from emergency situations, a decision support system for the attending physician, etc.
Conclusion
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/C. P. C./
Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683