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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 in response to applicant arguments filled on 10/17/2025 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 configuring algorithms based on inputs. The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity by identifying and reporting events preceding a pattern in a set of user data. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two:
This 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 machine readable storage media such it amounts to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional element of receiving and outputting information, which are considered limitations directed to insignificant extra-solution activity that does not amount to an inventive concept because the limitations do not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, the claimed receiving limitations are incidental to the performance of the recited abstract idea of identifying and reporting events preceding a pattern in a set of user data. See: MPEP 2106.05(g).
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. 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).
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 not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
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.”
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 Paik et al. (US 2024/0177836 A1) in view of Soori-Arachi.
In claim 1 Paik 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. 5 and 10);
configuring the medical algorithm based on the inputs (Para. 5 and 10); 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 (Para. 244 and 272).
As per claim 2, Paik 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. 327);
wherein the operations comprise one or more rules (327); 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, and
wherein the notifications correspond to the operations (para. 192).
As per claim 3, Paik 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 (Para. 10, 105, and 198).
As per claim 4, Paik 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. 8 and 20).
As per claim 5, Paik teaches the one or more non-transitory machine-readable storage media of claim 11, wherein the group comprises multiple steps (Para. 154).
As per claim 6, Paik teaches the one or more non-transitory machine-readable storage media of claim 5, wherein the medical algorithm comprise multiple groups, each group comprising multiple steps (Para. 255 and 289) ; and wherein steps in a group among the multiple groups are executable independently of steps in other groups among the multiple groups (Para. 155 and 255).
As per claim 7, Paik 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. 282).
As per claim 10, Paik 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. 12 and 240).
As per claim 11, Paik 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 test result values for parameters associated with one or more assays (Para. 219 and 223); and
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 (Para. 126);
wherein executing the medical algorithm comprises:
when the group is identified during execution of the medical algorithm, executing the group independently of other groups in the medical algorithm (Para. 289);
Paik does not explicitly teach however Soori-Arachi 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 (Para. 124 wherein “steps are generally described once per aspect, but this does not mean they must occur once, or that they may only occur once each time a process, method, or algorithm is carried out or executed. Some steps may be omitted in some embodiments or some occurrences, or some steps may be executed more than once in a given aspect or occurrence.” i.e. steps can be executed steps once per result value. See also Para. 225 and 325 ); and
Paik further 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 at least one of: (i) a notification triggered by execution of the group, or (ii) 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 (e.g., multi-task model for related categories and multiple single models for unrelated categories). Additional descriptors such as severity may also be inferred by the model for each candidate abnormality (e.g., a lesion detected in the spine may have a corresponding severity score or indicator). [0139] The image query function disclosed herein enables an image to be queried to obtain the results of the multiple abnormality category detections. At any point during image interpretation, the user may initiate a query using a designated mouse button, a keyboard hotkey, voice command (“What's this?”), or any other suitable user input. At the time of query, the image position can be defined either using the mouse or by other computer input devices such as an eye-tracking device. In some embodiments, when a candidate abnormality category (e.g., a candidate lesion) is close enough to the designated image location and has a probability or score above a given threshold, this result is presented to the user and a full text sentence describing this finding is generated (e.g., a computer-finding). In some cases, the user will then be prompted to either accept or reject the sentence into the findings section of the medical report.” i.e. the user can accept or reject the AI findings after processing different models to predict patient treatment information).
It would have been obvious to one of ordinary skill in the art at the time of filling to combine the system and method for artificial intelligence assisted image analysis as taught in Paik with the systems and methods for artificial intelligence based warning of potential health concerns that utilizes rules based algorithms and signal preprocessing tasks as taught in Soori Arachi (Para. 44). The well-known elements described are merely a combination of old elements, and in combination, each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 12, Paik 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. 139).
As per claim 14, Paik teaches the one or more non-transitory machine-readable storage media of claim 11, 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 (Para. 20 and 120); and wherein the method performed by the one or more processing devices further comprises displaying the report together with the one or more images (Para. 20 and 120).
As per claim 15, Paik teaches the one or more non-transitory machine-readable storage media of claim 14 and the medical images of patient as seen in figure 5. Paik does 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, Paik 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. 103).
As per claim 17, Paik 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. 286); and
wherein the medical algorithm is executed based on the information (Para. 286).
As per claim 19, Paik teaches the system of claim 18, wherein the one or more processing devices are external to the one or more test instruments (Para. 132 and 141).
As per claim 20, Paik teaches the system of claim 18, wherein the one or more processing devices are internal to one or more of the test instruments (Para. 132).
As per claim 21, Paik teaches the system of claim 18, 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 (Para. 20 and 296) ; and wherein the medical algorithm further comprises displaying the report together with the one or more images (Para. 22).
As per claim 22, Paik teaches the system of claim 18, 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. 139)
Claim 18 recites substantially similar limitations as seen above and hence are rejected for similar rationale as noted above.
Response to Arguments
The Applicant argues the 101 rejection. The Applicant states that the current claims are similar to In re Angello where the board reversed the 101 rejection. The board stated that the examiner did not explain how any of the processes recited in claim 39 relate to managing personal behavior or relationship or interactions between people. The Examiner respectfully disagrees. The current claims describe rules that are used to arrange/organize data. Organizing user data is directed towards the abstract idea of organizing human activity. The Examiner notes that Organizing human activity includes “ managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions).”
The Applicant argues that the current claims are more similar to Example 37, claim 2 where it found to be eligible since it does not recite a judicial exception. The Examiner respectfully disagrees. The current claims are not similar to claim 2 of Example 37 where the claims where directed to automatically moving the most used icons to a position on the GUI closest to the start icon of the computer system based on the determined amount of use. The current claims analyze data/follow rules in a generic way.
Applicant arguments with respect to the art rejection for claim 11 are moot in view of new grounds of rejection as noted above.
Applicant argues the art rejection of claim 1. The Applicant states that Paik does not teach configuring a medical algorithm based on inputs and outputting a display that includes a representation of the medical algorithm, where the medical algorithm is later executable by one or more computing devices. The Examiner respectfully disagrees. It is not clear how the configuring of the algorithms is based on the inputs? The Examiner notes that all learning algorithms process/configure information based on inputs.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/ Primary Examiner, Art Unit 3687
Prosecution Insights