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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/092026 has been entered.
Status of Claims
This action is in response to applicant arguments filled on 07/08/2026 for application 18/528941.
Claims 11 and 18 have been amended.
Claims 8-9 have been canceled..
Claims 1-7 and 10-22 are currently pending and have been examined.
Detailed Action
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 10-22 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) without significantly more.
Step 1:
Claims 1-7 and 10-22 are drawn to a method and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claims 11 and 18 recites receiving test result values associated with a patient, evaluating the test result, and predicting a potential medical condition based on the analysis. These limitation recite a mental process because they encompass observation, evaluations, and judgments that may be performed in the human mind or with the aid of a pen and paper. More particularly, a person may review patient test results, apply predetermined rules to those results, and reach a conclusion concerning a potential medical condition. Accordingly, the claim recites the abstract idea of evaluating patient medical information according to rules to predict a medical condition.
Under Step 2A, Prong Two.
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional element including a non-transitory media, and an algorithm such that they amount to no more than mere instruction to apply the exception using generic computer components. In addition, the claims recite receiving a user selection of a medical algorithm and receiving the test result values constitute data selection and gathering performed for use in the recited evaluation. Outputting a report constitutes post solution activity that merely communicates the result of the evaluation. In addition, the claims recite executing the group independently of other groups in the medical algorithm and outputting a report containing results produced by executing the group prior to obtaining results of execution of other groups. These steps do not recite a particular processor architecture, scheduling technique, memory arrangement or other specific technological mechanism by which the independent execution and early output are achieved. Instead, the claim recites the desire result of making one group’s report available before the other groups have completed. Thus, these limitations do not reflect an improvement to computer functionally or another technology and do not apply the abstract idea using a particular machine.
The predicted medical condition is merely reported. The claim does not require administering treatment, controlling medical equipment, etc. Limiting the abstract evaluation to patient test results and medical algorithms therefore merely places the abstract idea within a particular field of use. Accordingly, the claim as a whole is directed to the abstract idea and does not integrate the abstract idea into a practical application.
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements, considered As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f). receiving, data, executing rules using generic computer components, organizing processing operations, and outputting results are well understood routine and conventional computer functions. The claimed arrangement performs the evaluation more quickly or makes a partial result available sooner, but it does so without reciting a specific unconventional technical implementation.
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion:
“Examples of non-transitory machine-readable storage media include read-only memory, an optical disk drive, memory disk drive, and random access memory (RAM). At least part of the devices, systems, and processes described in this specification may be implemented or controlled using a computing system comprised of one or more processing devices and memory storing instructions that are executable by the one or more processing devices to perform various control operations. The devices, systems, and processes described in this specification may be configured, for example, through design, construction, formulation, arrangement, placement, programming, operation, activation, deactivation, and/or control.”
“The inputs may include parameters, predefined values, and operators. The method may include receiving, from the display, an instruction corresponding to an action to take with respect to the medical algorithm. The operations may include rules configured to evaluate test result values for parameters against respective predefined values based on respective operators. The action may include verifying the medial algorithm and, in response to the instruction, the method performed by the one or more processing devices may include outputting a second user interface configured to receive mock or prior test result values for the parameters. The method performed by the one or more processing devices may include: executing the medical algorithm using the mock or prior test result values received via the second user interface; and outputting a report representing one or more results produced by executing the medical algorithm using the or prior mock test result values. The report may include one or more of the rules, one or more test result values received via the second user interface.”
Independent execution may include parallel execution, where at least part of the steps and rules in a given group are executed concurrently with execution of at least part of the steps and rules in in one or more other groups of the medical algorithm. For example, referring to Fig. 9, at least part of the steps and rules in group 50 may be executed at a same time as the step and rule of group 48. In some implementations,
independent execution may include steps and rules in one group executing after all steps and rules in another group have been executed. In the example of Fig. 9, steps 21x and 29x may execute concurrently, but steps 32x and 35x of group 50 may execute after steps 21x and 29x. In some implementations, steps and rules from two, three, four, five, six, or more groups may be executed independently.
The claims recite the additional element of receiving and outputting information, which amounts to extra-solution activity concerning mere data gathering and displaying. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-7, 10, 12-17, and 19-22 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries 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.
Claim(s) 1-7 and 10-22 s/are rejected under 35 U.S.C. 103 as being unpatentable over Gorlinger (US 2016/0161510 A1) in view of Brown et al. (US 8275803 B2)
In claim 1 Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 11, wherein the operations comprise:
outputting a user interface configured to receive inputs to use in a medical algorithm (Para. 12);
configuring the medical algorithm based on the inputs (Fig. 5); and
outputting a display, the display comprising a representation of the medical algorithm, the representation presenting operations to be executed by the medical algorithm, and the representation relating the operations to one or more notifications triggered based on the operations (Fig. 5).
As per claim 2, Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 1,
wherein the inputs comprise one or more parameters, one or more predefined values, one or more operators, and the one or more notifications (Para. 5);
wherein the operations comprise one or more rules (Para. 5); and
wherein a rule of the one or more rules is configured to evaluate a test result value for one of the parameters against one of the predefined values based on one of the operators (Para. 5, and
wherein the notifications correspond to the operations (Fig. 6).
As per claim 3, Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 2, wherein the one or more parameters comprise one or more of the following: a parameter associated with viscoelastic testing, a parameter associated with blood gas testing, a parameter associated with platelet function testing, a parameter associated with coagulation testing, or a parameter associated with activated clotting time (ACT) testing (abstract).
As per claim 4, Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 11, wherein the method comprises receiving inputs comprising information about at least one of (i) whether the patient is bleeding or has non-bleeding, thrombosis, (ii) a clinical setting, (iii) a stage of surgery the patient is undergoing, (iv) a medical condition of the patient, (v) a bodyweight of the patient, (vi) an age of the patient, (vii) a sex of the patient, (viii) a medical diagnosis for the patient, or (ix) a treatment that the patient has undergone or is undergoing (Para. 13).
As per claim 5, Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 11, wherein the group comprises multiple steps (Fig. 5).
As per claim 6, Gorlinger in view of Brown teach the one or more non-transitory machine-readable storage media of claim 5. Gorlinger does not explicitly teach however Brown teachees, wherein the medical algorithm comprise multiple groups, each group comprising multiple steps (claim 1 and claim 5) ; and wherein steps in a group among the multiple groups are executable independently of steps in other groups among the multiple groups (claim 1 and claim 5). The motivation to combine references is the same as seen in claim 11.
As per claim 7, Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 1, wherein the display comprises an element that is selectable to verify the medical algorithm, the element being configured to cause output of the instruction (Para. 74).
As per claim 10, Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 11, wherein the report comprises a time with exaction of the one or more rules (para. 51 ).
As per claim 11, Gorlinger teaches the one or more non-transitory machine-readable storage media storing instructions that are executable by one or more processing devices to perform a method comprising:
Receiving a user selection of a medical algorithm that corresponds to a potential medical condition of a patient (Para. 12 wherein “ system to select a particular algorithm of a plurality of the algorithms for interpreting the blood test result data in response to the user input indicative of the clinical setting of the patient”); and
receiving test result values for parameters associated with one or more assays, the test result values being for the patient (abstract);
executing a medical algorithm using the test result values, the medical algorithm comprising rules configured to evaluate the test result values, and the medical algorithm comprising groups comprised of one or more steps, where a step in a group comprises one or more of the rules, and where the group is configured to predict a medical condition in a patient (Fig. 5);
wherein executing the medical algorithm comprises:
Gorlinger does not explicitly teach however Brown teaches:
when the group is identified during execution of the medical algorithm, executing the group independently of other groups in the medical algorithm (Claim 1, wherein a plurality of parallel implemented scoring modules are taught. See also claim 5);
Gorlinger further teaches:
when a series of steps is identified in the group during execution of the medical algorithm, executing the steps in the series in a sequence in which the steps are arranged in the series, where a step is executed once for a given test result value (fig. 5 wherein a series of steps are identified in the group during execution of the medical algorithm ); and
Brown further teaches teaches:
outputting a report containing results produced by executing the group prior to obtaining results of execution of the other groups, wherein the report comprises the one or more rules, values based on test result values associated with corresponding rules, and an alert triggered by execution of the group, the alert being indicative of the medical condition in the patient (Para. 138-139 wherein “ a single model can be trained to detect 50 different types of abnormalities using a multi-task learning (MTL) approach. In some embodiments, a combination of the multiple individual models and the single multi-task model approaches are used (Col. 20 1st Para. “It should be noted that Final merging and ranking is incremental, i.e., the machine provides the best so far answer as the computation on different nodes completes. Once all nodes complete, the final (top) answer(s) is delivered. Thus, in one embodiment, the final AnswerList and Answers are added to the original Question view, and the question answering process is complete”).
It would have been obvious to one of ordinary skill in the art at the time of filling to modify the medical algorithm of Gorlinger using Brown’s parallel and incremental processing, such that the diagnostic groups execute independently and that a group result is provided before the remaining groups finish. One of ordinary skill would of done this in order to reduce processing and reporting delays and provide clinicians with available diagnostic information more promptly.
As per claim 12, Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 11, wherein the values based on the test result values comprise at least one of (i) a test result value, (ii) a maximum value that is less than a corresponding test result value, or (iii) a minimum value that is greater than a corresponding test result value (Para. 68).
As per claim 14, Gorlinger in view of Brown teach the one or more non-transitory machine-readable storage media of claim 11. Gorlinger does not explicitly teach however Brown teaches wherein the test result values are received in metadata of one or more images or are received from an optical character recognition of the one or more images (abstract and Fig. 1A wherein “such as documents containing textual data and/or image data, integrating and accessing structured sources and storing, indexing and searching for artifacts based on discovered semantic content”); and wherein the method performed by the one or more processing devices further comprises displaying the report together with the one or more images (Fig. 1 A). The motivation to combine references is the same as seen in claim 11.
As per claim 15, Gorlinger in view of Brown teach the one or more non-transitory machine-readable storage media of claim 14 and the medical images of patient as seen in figure 5. Gorlinger and Brown do not explicitly teach wherein the images are of a reaction curve however the Examiner notes that a limitation regarding the specific information displayed durations is drawn to non-functional descriptive material and is not functionally involved with the system. The recited system would perform the same regardless of the specific data being displayed. Thus, this descriptive material will not distinguish the claimed invention from the prior art in terms of patentability, see In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 404 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). See also MPEP 2106.
As per claim 16, Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 11, wherein a test result value for a parameter comprises (i) a final value for the parameter or (ii) a value for the parameter that is non-final (Para. 70).
As per claim 17, Gorlinger teaches the one or more non-transitory machine-readable storage media of claim 11, wherein the method performed by the one or more processing devices comprises receiving information about at least one of (i) whether the patient is bleeding, (ii) a type of surgery that the patient is undergoing, (iii) a stage of the surgery, or (iv) a medical condition of the patient (Para. 70); and
wherein the medical algorithm is executed based on the information (Fig. 5).
As per claim 19, Gorlinger teaches the system of claim 18, wherein the one or more processing devices are external to the one or more test instruments (Fig. 1).
As per claim 20, Gorlinger teaches the system of claim 18, wherein the one or more processing devices are internal to one or more of the test instruments (Fig. 1).
Claim 18 and 21-22 recites substantially similar limitations as seen above and hence are rejected for similar rationale as noted above.
Response to Arguments
Applicant arguments with respect to the art rejection are moot in view of new grounds of rejections necessitated by claim amendments.
The Applicant argues the 101 rejection. The Applicant states that the claims define a particular way of structure and executing a medical algorithm, not a result-oriented instruction to apply medical rules on a generic computer. The Examiner respectfully disagrees. The claims do not recite a specific improvement to computer functionality, medical testing or other technical field. Instead, the claims use generic computer components to evaluate test result values and produce predictive information. Here the claims are directed to an abstract idea of evaluating medical information according to specific rules, rather than to a particular technological implementation or improvement.
The Applicant argues that the claims are analogous to McRO vs Bandai Namco where rule-based computer implemented claims were eligible because they used particular rules in a process specifically designed to achieve an improved technological result. Since the claims specify how the rules are arranged, how groups are executed… and how results are output before other group execution results are obtained. The Examiner respectfully disagrees. In McRo the rules changed how the computer-generated animation and enabled the automation of a specific technological process. Here the rules used in the claims do not change the operation of the computer or assay technology. The claimed result remains the prediction of a patient medical condition from test result values using rules.
Other Applicant arguments are addressed in the updated 101 rejection above.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 MAROUN P KANAAN whose telephone number is (571)270-1497. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/ Primary Examiner, Art Unit 3687
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