DETAILED ACTION
Notices to Applicant
This communication is a final rejection. Claims 22-42, as filed 03/04/2026, are currently pending and have been considered below.
Priority is generally acknowledged to 16/598,521 filed 10/10/2019 and 62/743,819 filed 10/10/2018.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claim Objections
Claims 29 and 36 are objected to because of the following informalities. Both contain a superfluous “a” in the following portion: “including a historical value a and a recent value”.
Appropriate correction is required.
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 22-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture.
Step 2A Prong One
The broadest reasonable interpretation of the claimed invention includes analysis of patient data to determine trends and provide feedback on treatment decisions. Analysis to determine trends can practicably be performed in the human mind, therefore the claimed invention recites one or more mental processes. Additionally, but for general computer terminology such as displays, presenting historical trend data to provide feedback on treatment decisions encompasses certain methods of organizing human activity because these steps are analogous to steps a provider would follow when reviewing patient vital and lab data and providing a colleague treatment recommendations.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. For example, claims 23-25 recite additional details about the data that is analyzed and the information conveyed while providing treatment feedback.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements:
amount to mere instructions to apply an exception. For example, displaying data as a fishbone diagram as in claim 22, a table as in claim 26, or a line graph as in claim 28 amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0050]-[0052], see MPEP 2106.05(f)). Similarly, using a display to provide real-time feedback amounts to using a computer to automate the abstract ideas because computers analyze and display data quickly.
add insignificant extra-solution activity to the abstract idea. For example, receiving data from one or more data providers as in claim 22 and 27 amounts to mere data gathering and selecting a particular data source or type of data to be manipulated, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. 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. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields. For example, analyzing the patient information and organizing it into fishbone diagrams amounts to electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii), and/or storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. 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. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
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.
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 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 22-42 are rejected under 35 U.S.C. 103 as being unpatentable over Abou-Hawili (US20160239619A1) in view of Ayers (US20140257861A1).
Regarding claim 22, Abou-Hawili discloses: An anesthesia information management system (AIMS), comprising: an information management component, including:
--a memory configured to store at least one patient laboratory test data received over time from a first data provide (“The single patient interface 1200 also displays patient data 1208 associated with the patient including physiological data, early warning scores, trending information, laboratory results, and the like and/or clinical data 1210 including scheduled clinical activities associated with the patient,” [0054]);
--a diagram generating component programmed to generate fishbone diagram image data from the received at least one patient laboratory test data (“The laboratory results interface 1300 displays the laboratory data in a graphical fishbone presentation 1300;” FIGs. 10-15);
--a display device programmed to concurrently display, responsive to user instruction:
-- one or more fishbone diagrams generated by the diagram generating component, each of the one or more fishbone diagrams including a plurality of sections, each section corresponding to a laboratory test parameter grouping for displaying the at least one patient laboratory test data (Fishbone lab results in FIGs. 10-15; “The laboratory results interface 1300 displays the laboratory data in a graphical fishbone presentation 1306,” [0055]);
--at least a (trending information in [0055]-[0056]; arrows showing trends in fishbone graphs in FIGs. 10-15).
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Abou-Hawili discloses fishbone diagrams displaying trends in lab data represented by an arrow, but does not expressly disclose that the lab data is displayed with time stamps or that it includes a recent value and a historical value for the same parameter. For example, FIG. 14 shows trends for two measurable parameters (see the downward arrow next to 0.6 and the upward arrow next to 226).
Ayers teaches:
--displaying lab results alongside the time stamp of the result (“For example, the medical device 100 may be one of those within the IDEXX VetLab® Suite that delivers information on blood chemistries, proteinuria, electrolytes, hematology, endocrinology and blood gases,” [0026]; “The processor 108 further accesses the memory 110 to retrieve stored historical data 114, or past medical results, and may combine the historical data 114 with the received medical readings to be output to the printer 102 or the display device 104 through an output interface 116,” [0025]; “the report is provided in a layout that has rows and columns, so that all current results are presented in one column, and all past results are presented in a separate column,” [0035]; “Dates and times corresponding to the date and time for performing the current tests to obtain the current results and for when the previous results were obtained are also included in the report,” [0048]; “The tests results pertaining to “Chemistry” are positioned in adjacent rows, while the tests pertaining to “Immunoassay” are shown in a separate section of the layout,” [0045]); and
--a data trend generating component programmed to generate trend image data from the at least one patient laboratory test data stored in the memory (trend in FIGs. 4 and 7).
One of ordinary skill in the art would have been motivated before the effective filing date to expand Abou-Hawili’s at-a-glance fishbone display of laboratory data (such as 1306 in FIG. 13) with the historical value display of Ayers because storing and displaying these data points together would allow a clinician to assess the magnitude and rate of change of each parameter and thus improve patient health (see Ayers [0007]).
Additionally, it can be seen that each element is taught by either Abou-Hawili or Ayers. The display element(s) of Ayers do not affect the normal functioning of the elements of the claim which are taught by Abou-Hawili. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Abou-Hawili with the teachings of Ayers since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Regarding claim 23, Abou-Hawili discloses: wherein the one or more fishbone diagrams include: first image data associated with the first patient laboratory test data, the first image data including a most recently received value of a first measurable parameter; and second image data associated with a second patient laboratory test data, the second image data including a most recently received value of a second measurable parameter (1306 in FIG. 13 shows several image data sections associated with several measurable parameter. For example “0.6” with a downward arrow and “6.2” with an upward arrow).
Regarding claim 24, Abou-Hawili does not expressly disclose but Ayers teaches: wherein the one or more fishbone diagrams further include: a first time associated with the most recently received value of the first measurable parameter and a first unit of measure of the first measurable parameter; and a second time associated with the most recently received value of the second measurable parameter and a second unit of measure of the second measurable parameter (“data within column 304 includes the current result of the medical test with a numerical value and unit,” [0041]; FIG. 3; “Dates and times corresponding to the date and time for performing the current tests to obtain the current results and for when the previous results were obtained are also included in the report,” [0048]).
The motivation to combine is the same as in claim 22.
Regarding claim 25, Abou-Hawili does not expressly disclose but Ayers teaches: wherein the first time associated with the most recently received value of the first measurable parameter includes at least one of: when the most recently received value of the first measurable parameter was obtained, when the most recently received value of the first measurable parameter was measured, and when the most recently received value of the first measurable parameter was provided, and the second time associated with the most recently received value of the second measurable parameter includes at least one of: when the most recently received value of the second measurable parameter was obtained, when the most recently received value of the second measurable parameter was measured, and when the most recently received value of the second measurable parameter was provided (“Dates and times corresponding to the date and time for performing the current tests to obtain the current results and for when the previous results were obtained are also included in the report,” [0048]).
The motivation to combine is the same as in claim 22.
Regarding claim 26, Abou-Hawili does not expressly disclose but Ayers teaches: wherein the historical trend data of the first set of patient laboratory test data is displayed as a first table corresponding to the first patient laboratory test data (“the report is provided in a layout that has rows and columns, so that all current results are presented in one column, and all past results are presented in a separate column. Further, past and current results of the same medical test performed on the same subject are presented in the same row,” [0035]).
The motivation to combine is the same as in claim 22.
Regarding claim 27, Abou-Hawili further discloses wherein the first set of patient laboratory test data provided from the first data provider is provided from a single data provider (patient information database 26 in FIG. 1; “the patient data is stored in the patient information database 26,” [0037]).
Regarding claim 28, Abou-Hawili further discloses: wherein the historical trend data of the first set of patient laboratory test data is displayed as a first line graph corresponding to the first patient laboratory test data (“The single patient interface 1200 also displays patient data 1208 associated with the patient including physiological data, early warning scores, trending information, laboratory results, and the like and/or clinical data 1210 including scheduled clinical activities associated with the patient,” [0054]; line chart for HR and SpO2 in FIGs. 11-12).
Regarding claims 29-35, the claims are substantially similar to claims 22-28 (respectively) and are rejected with the same reasoning.
Regarding claims 36-42, the claims are substantially similar to claims 22-28 (respectively) and are rejected with the same reasoning. The Examiner notes that Abou-Hawili further teaches memories with computer executable instructions configured to implement the software.
Response to arguments
Applicant's arguments filed 03/24/2026 have been fully considered and are discussed below.
Regarding the subject matter ineligibility rejections, Applicant argues that the claimed invention is not directed to a mental process or method of organizing human activity (Step 2A Prong One) the claim AIMS component comprising a memory and configured to generate trend image data from test data cannot practicably be performed in the human mind. Remarks pages 10-11. This is not persuasive. The abstract idea is the underlying cognitive operation of organizing lab test data, comparing that data with previous values, and communicating findings to inform treatment. Clinicians have followed these steps mentally for decades. The names software components and computer components merely amount to applying the abstract idea with a computer. They are claimed as the result they obtain, namely, generating fishbone image data and trends, not by any specific feature that goes beyond a conventional processor executing software.
Applicant argues that the claimed invention integrates any abstract idea into a practical application (Step 2A Prong Two) by improving the technical functioning of a clinical information management system, citing Enfish, McRO, and Core Wireless. Remarks pages 11-12. This is not persuasive. Each of these cases involved an improvement to the computer such as internal data storage architecture, animation processing rules, and display structure. Here, the object of the claims is to create a particular display of data for a human to review. The diagram generating and data trend generating components improve the clinician’s interpretation of patient lab trend, not the computer’s technical operation. The computer functions the same regardless of the label attached to the data (e.g., “historical” or “recent”) or the design of the generated report (i.e., a fishbone pattern). An improvement to information presentation for a human to review does not integrate the abstract idea into a practical application.
Applicant argues that the claimed invention amounts to significantly more than any abstract idea (Step 2B) because the Examiner has failed to prove “that the specific combination of an AIMS component with a diagram generating component, a data trend generating component, a memory configured to store time-indexed patient laboratory test data, and a display device programmed to display fishbone diagrams with laboratory test parameter groupings and historical trend data retrieved from memory was WRC at the time of the invention.” Remarks page 13. This is not persuasive because Applicant interprets the evidentiary standard of Berkheimer so broadly that it conflates eligibility with nonobviousness. As the Supreme Court emphasizes: “[t]he ‘novelty' of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Diehr, 450 U.S. at 188-89 (emphasis added). The Federal Circuit further guides that “[eligibility and novelty are separate inquiries.” Two-Way Media Ltd. v. Comcast Cable Commc' ns, LLC, 874 F.3d 1329, 1340 (Fed. Cir. 2017). Step 2B is concerned with whether additional elements are significantly more than the abstract idea. Here, the additional elements include the generic computer components, receiving data, and displaying data, not the data analysis underpinning the trend analysis and data arrangement. These additional elements do not require Berkheimer evidence because they fall under applying the abstract idea with a computer, receiving or transmitting data over a network and storing and retrieving information in memory. See MPEP 2106.05(d)(II) and MPEP 2106.05(f).
Regarding the prior art rejections, the Examiner notes that Applicant’s arguments are moot in view of the new grounds of rejection above containing Ayers. The Examiner analyzes the arguments below that are germane to this new combination. Applicant argues that Abou-Hawili and X-Series fail to disclose or suggest the anesthesia information management system (AIMS) of claim 22. This argument is not persuasive because the AIMS limitation is a field-of-use limitation that identifies the environment in which the data processing occurs. It does not introduce any structural requirements to the system or computer-readable medium. The method additionally invokes an AIMS component as a data source, but the BRI of this term includes a general purpose computer since such computers can output/input data during and after an anesthesia event. Abou-Hawili discloses a hospital information management component that meets all the structural limitations of the claims.
Applicant argues that Abou-Hawili’s directional arrows in FIG. 13 do not disclose a historical value and a recent value because the arrows indicate only the direction of the trend without displaying what the actual prior data point was at the prior time. This is not persuasive because Applicant does not consider the references in combination. Abou-Hawili’s arrows described in [0055] establish that the fishbone displays present trend information for lab test parameters. Ayers supplies the technique of generating a display of actual stored prior data points alongside current values with timestamps for two or more parameters. The rejection relies on this combination. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office Action (See MPEP 706.07(a)). Accordingly, THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant, can be reached on (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624
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