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 .
Response to Arguments
Applicant’s arguments are directed towards the newly amended claim language which have been fully considered but are not persuasive to overcome the rejections; however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by amendment.
With respect to the 101 rejection, the claim continues to describe data gathering steps followed by data manipulation to filter/sort in order to assign a sepsis level based on a data value. Not only is there no treatment or end therapeutic step, but there is no active data acquisition step, or transformation of the data using a novel algorithm. Accordingly, the 101 is maintained below.
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 1-7 and 21-23 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are determined to be directed to a judicial exception, specifically an abstract idea, without significantly more.
Step 1
The claimed inventions in claims 1-7 and 21-23 are directed to statutory subject matter as the claim(s) recite(s) a method of displaying data and determining sepsis.
Step 2A, Prong One
Claim 1 recites the following steps or instructions to “apply a set of rules…to the patient data…to assign…a sepsis level”, “display…a sepsis alert”, and “update the sepsis alert…in real time”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III). For example, the limitations concern data collection, data analysis presenting the results of data analysis, and updating the presentation based on updated data received, which could be done mentally. These limitations are nothing more than a medical professional examining data on a screen, noting when a data point is above the threshold for sepsis, making a note of that patient’s data indicating sepsis, and continuing to update and monitor the data coming in while updating the sepsis state.
Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claim 1 recites additional elements of “a display screen” with generic software display options, a “GUI”, and “a computing device” or “care provider device”. In addition, claim 1 recites additional data gathering steps to “receive…a feed of patient data”.
Step 2A, Prong Two
The above-identified abstract idea in each of independent Claim 1 is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and appear to be extra solution activity where data to be analyzed by the abstract idea is acquired or displayed.
More specifically, the additional elements of “a display screen” with generic software display options, a “GUI”, and “a computing device” or “care provider device” are generically recited computer elements in independent Claim 1 (and the respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claim 1 (and the respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and using mathematical concepts) using rules (e.g., computer instructions) executed by a computer (e.g “a display screen” and “a computing device” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and the respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claim 1 (and the respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons:
These claims require the additional elements of: “a display screen” and “a computing device”.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Additionally, the claimed “a display screen” and “a computing device” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for “a display screen” and “a computing device”. In fact, these elements are described as generic well understood routine and conventional components at ¶¶ 28 of the published application – “a server, a personal computer, a workstation, a mobile device (e.g., a cellular phone, a smart phone, a computing tablet, and so on), or any other type of computing device.” This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1-7 and 21-23 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, “a display screen” and “a computing device” in Claims 1-7 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1 and respective dependent claims, do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 & 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Newberry (US 2018/0214088; hereinafter “Newberry”).
Newberry discloses a computing device comprising a display screen, the computing device being configured to: display on the display screen a menu listing one or more electronic medical records (EMRs) of one or more patients, the menu listing the one or more EMRs while the one or more EMRs are in an un-launched state, wherein the computing device is a care provider device and the display screen is a display screen of the care provider device (e.g. ¶¶ 222, 261, etc.), receive, in real time, a feed of patient data from one or more EMR systems, the feed including one or more values for each of a plurality of parameters for each of a plurality of patients (e.g. ¶¶ 262-273); apply a set of rules to the patient data received from the feed to assign, for each patient, a sepsis level from a set of possible sepsis levels (e.g. ¶¶ 146-152); display screen a sepsis alert graphical user interface (GUI) accessible from the menu, wherein the sepsis alert GUI displays, for each patient, a sepsis level element identifying the assigned sepsis level for that patient and a limited list of criteria that triggered the identified sepsis level (e.g. ¶¶ 262-273), the limited list of criteria obtained from the one or more EMRs and comprising a subset of the patient parameters that triggered the assignment of the identified sepsis level wherein displaying the limited list of criteria reduces processing demands on the computing device by limiting an amount of the received patient data that is processed for display (e.g. ¶¶ 146-152); and dynamically update the sepsis alert GUI in real time as the patient data is received over the feed, without requiring the one or more EMRs to be launched, wherein each criterion in the limited list of criteria is selectable to launch a pop-up UI with additional information relating to the identified sepsis level and enable at least the selected criterion to be seen within the pop-up UI, and wherein the sepsis alert GUI is displayed while the one or more EMRs are in an un-launched state (e.g. ¶¶ 242).
Regarding claim 2, Newberry discloses the sepsis level element is selectable to launch a second pop-up UI with additional information for each criteria of the limited list of criterion and remaining criteria that did not trigger the identified sepsis level (e.g. ¶¶ 242-248).
Regarding claim 3, Newberry discloses the limited list of criteria includes a systemic inflammatory response syndrome (SIRS) criterion, and wherein the SIRS criterion is selectable to launch a SIRS pop-up UI that enables a plurality of patient parameters that triggered the SIRS criterion to be displayed within the SIRS pop-up UI (e.g. ¶¶ 146-152).
Regarding claim 4, Newberry discloses the plurality of parameters includes a diagnosed sepsis level (e.g. ¶¶ 146).
Regarding claim 5, Newberry discloses a first sepsis level element for a first patient includes a mismatch flag indicating that the diagnosed sepsis level for the first patient does not match a system-determined sepsis level determined based on patient parameters for the first patient received from the one or more EMRs (e.g. ¶¶ 48).
Regarding claim 6, Newberry discloses a first sepsis level element for a first patient includes a snooze icon indicating that an identified sepsis level of the first patient has been snoozed (e.g. ¶¶ 277).
Regarding claim 7, Newberry discloses the snooze icon is removed responsive to a determination that the identified sepsis level for the first patient has changed, the determination based on patient parameters received from the one or more EMRs (e.g. ¶¶ 242-248, etc.).
Regarding claim 21, Newberry discloses the one or more EMR systems comprise a remote EMR database accessible via a secured hospital interface, wherein the EMR database is configured to control access to patient electronic medical records such that only authorized healthcare providers may access the electronic medical records (e.g. ¶¶ 263 – “In one aspect, the user device 2610 or biosensor 100 may communicate the health data to a health care facility 2650, such as a doctor's office, hospital, etc.”).
Regarding claim 22, Newberry discloses the computing device is further configured to receive patient data from one or more of a laboratory information system, a pharmacy system, one or more patient monitoring devices, an imaging service, and wherein the set of rules is applied to the patient data received from the one or more EMR systems and the one or more of the laboratory information system, the pharmacy system, the one or more patient monitoring devices and the imaging service (e.g. ¶¶ 262-269).
Regarding claim 23, Newberry discloses the sepsis alert GUI displays, for each patient, a patient information column, a sepsis level column comprising the sepsis level element, and a sepsis criteria column comprising the limited list of criteria, wherein the patient information column is displayed to the left of the sepsis level column, and the sepsis level column is displayed to the left of the sepsis criteria column and wherein each criterion of the limited list of criteria is displayed as a separate selectable visual element within the sepsis criteria column, wherein a number of separate selectable visual elements displayed in the sepsis criteria column for a given patient corresponds to a number of criteria met by that patient (e.g. ¶¶ 146-152).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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