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 .
Applicant filed a response dated 12/4/2025 in which claims 1-7 and 13-20 have been amended, claim 12 has been canceled. Thus, the claims 1-11 and 13-20 are pending in the application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/4/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 13-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1 (and elsewhere, where applicable), lines 5-10, if the missing parameters are not present in the set of parameters inputted by the user, then how does one come to a conclusion that some parameters are missing. The plurality of parameters comprises a set of parameters and the missing parameters. However, the claim does not describe how the missing parameters were identified. The determining step does not describe how the determination was carried out in identifying that the set of parameters inputted by a user is incomplete and some parameters are missing. In lines 15-17, a value is being assigned to the missing parameters to generate a complete parameter set, however, it is not clear if there is a value associated with a set of parameters in order to generate a complete parameter set. This renders the claim indefinite.
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 1-11 and 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of determining and transmitting a trauma-triage category for the patient without significantly more.
Examiner has identified claim 20 as the claim that represents the claimed invention presented in independent claims 1, 14, and 20.
Claim 20 is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
The claim 20 describes a method comprising a series of steps, e.g., receiving, by the first processing circuitry of a mobile computing device via a user interface of the mobile computing device, user input comprising a set of parameters indicating a condition of a trauma patient; wirelessly transmitting, by the first processing circuitry, the set of parameters to a remote server; receiving, by second processing circuitry of the remote server, the set of parameters; determine, based on the user input of the set of parameters, one or more missing parameters from a plurality of parameters representative of the condition of the trauma patient, the plurality of parameters being used by one or more machine-learning algorithms to determine a trauma-triage category for the trauma patient, wherein the plurality of parameters comprises the set of parameters and the one or more missing parameters; calculate, based on a set of training data previously used to train the one or more machine-learning algorithms, a default value for the one or more missing parameters, wherein the set of training data comprises values for the missing parameter from a plurality of past patients different than the trauma patient; impute the default value for the one or more missing parameters into the plurality of parameters representative of the condition of the trauma patient to generate a complete parameter set for the trauma patient; applying, by the second processing circuitry, the complete parameter set to the one or more machine-learning algorithms trained to determine, based on the complete parameter set, the trauma-triage category for the trauma patient, wherein the trauma-triage category for the trauma patient indicates a trauma-triage recommendation for the trauma patient; wirelessly transmitting, by the second processing circuitry to the mobile computing device, the trauma-triage category for the trauma patient; receive, by the first processing circuitry from the remote server, the trauma-triage category; and outputting for display, by the first processing circuitry via the user interface, an indication of the trauma-triage category. These limitations (with the exception of italicized limitations), under their broadest reasonable interpretation, describe the abstract idea of determining and transmitting a trauma-triage category for the patient. Furthermore, if a claim limitation, under its broadest reasonable interpretation, covers interactions between people, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. The additional elements of a first/second processing circuitry, a mobile computing device, a user interface, wirelessly feature, a remote server, and one or more machine-learning algorithms do not necessarily restrict the claim from reciting an abstract idea. Thus, the claim 20 recites an abstract idea (Step 2A-Prong 1: YES).
This judicial exception is not integrated into a practical application because the additional elements of a first/second processing circuitry, a mobile computing device, a user interface, wirelessly feature, a remote server, and one or more machine-learning algorithms result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a first/second processing circuitry, a mobile computing device, a user interface, wirelessly feature, a remote server, and one or more machine-learning algorithms are recited at a high level of generality, and under their broadest reasonable interpretation comprises a generic computing device. The presence of a generic computing device does nothing more than to implement the claimed invention (MPRP 2106.05(f)). The additional elements of a first/second processing circuitry, a mobile computing device, a user interface, wirelessly feature, a remote server, and one or more machine-learning algorithms are no more than mere instructions to apply the exception using a generic computer element. Therefore, the recitations of additional elements do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 20 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of a first/second processing circuitry, a mobile computing device, a user interface, wirelessly feature, a remote server, and one or more machine-learning algorithms are recited at a high level of generality in that it result in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these elements provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 20 is not patent eligible.
Similar arguments can be extended to other independent claims 1 and 14 and hence the claims 1 and 14 are rejected on similar grounds as claim 20.
Dependent claims 2-11, 13, and 15-19 further define the abstract idea that is present in their respective independent claims 1, 14, and 20 and thus correspond to Certain Methods of Organizing Human Activity and hence are abstract in nature for the reasons presented above. Dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 2-11, 13, and 15-19 are directed to an abstract idea. Thus, the claims 1-11 and 13-20 are not patent-eligible.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 11, 13-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Batchinsky et al., US Patent No. 9,532,721 in view of Patil et al., US Patent Application No. 2021/0109908.
Regarding claim 20, Batchinsky discloses a method comprising:
receiving, by first processing circuitry of a mobile computing device via a user interface of the mobile computing device, user input comprising a set of parameters indicating a condition of a trauma patient (col. 20, lines 30-39, mobile device carried by a single patient that is monitored remotely by a care provider; col. 20, lines 51-col. 21, line 7; claim 11, claim 16);
wirelessly transmitting, by the first processing circuitry, the set of parameters to a remote server (col. 12, lines 41-45, wirelessly, Fig. 5; col. 20, lines 30-39, mobile device carried by a single patient that is monitored remotely by a care provider; col. 20, lines 51-col. 21, line 7; claim 11, claim 16);
receiving, by second processing circuitry of the remote server, the set of parameters (col. 20, lines 30-39, mobile device carried by a single patient that is monitored remotely by a care provider; col. 20, lines 51-col. 21, line 7; claim 11, claim 16);
determine, based on the user input of the set of parameters, one or more missing parameters from a plurality of parameters representative of the condition of the trauma patient, the plurality of parameters being used by one or more machine-learning algorithms to determine a trauma-triage category for the trauma patient, wherein the plurality of parameters comprises the set of parameters and the one or more missing parameters (col. 1, lines 28-54, heart rate, blood pressure, respiratory rate and oxygen saturation, incomplete knowledge of patient conditions implies missing parameters; lack of accurate data; mask the patients true conditions; col. 8, lines 9-col. 9, lines 48, ANN, derived patient signal implies original parameter were not available (i.e., missing));
calculate, based on a set of training data previously used to train the one or more machine-learning algorithms, a default value for the one or more missing parameters, wherein the set of training data comprises values for the missing parameter from a plurality of past patients different than the trauma patient;
impute the default value for the one or more missing parameters into the plurality of parameters representative of the condition of the trauma patient to generate a complete parameter set for the trauma patient (col. 1, lines 62-col. 2, lines 2; col. 8, lines 9-col. 9, lines 48);
applying, by the second processing circuitry, the complete parameter set to the one or more machine-learning algorithms trained to determine, based on the complete parameter set, the trauma-triage category for the trauma-triage patient, wherein the trauma-triage category for the trauma patient indicates a trauma-triage recommendation for the trauma patient (col. 16, lines 39-51; claim 16);
wirelessly transmitting, by the second processing circuitry to the mobile computing device, the trauma-triage category for the trauma patient (col. 12, lines 41-45, wirelessly, Fig. 5; col. 20, lines 30-39);
receiving, by the first processing circuitry from the remote server, the trauma-triage category (claim 16; col. 20, lines 30-39; col. 20, lines 51-col. 21, line 7); and
outputting for display, by the first processing circuitry via the user interface, an indication of the trauma-triage category (claim 12).
Batchinsky does not specifically disclose
calculate, based on a set of training data previously used to train the one or more machine-learning algorithms, a default value for the one or more missing parameters, wherein the set of training data comprises values for the missing parameter from a plurality of past patients different than the trauma patient;
impute the default value for the one or more missing parameters.
However, Patil discloses
calculate, based on a set of training data previously used to train the one or more machine-learning algorithms, a default value for the one or more missing parameters, wherein the set of training data comprises values for the missing parameter from a plurality of past patients different than the trauma patient ([0001]-[0008], machine/deep learning models, estimating missing parameter value, average parameter value of the parameter under consideration);
impute the default value for the one or more missing parameters ([0001]-[0008], machine/deep learning models, estimating missing parameter values, average parameter value of the parameter under consideration).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Batchinsky with the above-noted disclosure of Patil. The motivation for combining these references would have been to provide proper care of the trauma patient.
Regarding claim 11, it has been held that a wherein clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim (Texas Instruments Inc. v. International Trade Commission 26, USPQ2d 1010 (Fed. Cir. 1993); Griffin v. Bertina, 62 USPQ2d 1431 (Fed. Cir. 2002); Amazon.com Inc. v. Barnesandnoble.com Inc., 57 USPQ2d 1747 (CAFC 2001)), therefore, wherein, the one or more machine-learning models comprise restricted cubic splines that model nonlinear determinative factors among the plurality of parameters will not differentiate the claims from the prior art.
Regarding claim 13, Patil discloses
wherein the default value comprises an average value of the one or more missing parameters calculated from a set of training data used to train the one or more machine-learning models ([0001]-[0008]), average parameter value of the parameter under consideration).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Batchinsky with the above-noted disclosure of Patil. The motivation for combining these references would have been to provide proper care of the trauma patient.
Claims 1 and 14 are substantially similar to claim 20 and hence rejected on similar grounds.
Claims 2-3, 5, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Batchinsky et al., US Patent No. 9,532,721 in view of Argenbright et al., US Patent Application No. 2003/0208377.
Regarding claim 2, Argenbright discloses wherein the trauma-triage category further indicates a Need for Emergent Intervention within 6 hours (NEI-6) designation for the trauma patient ([0003], immediate treatment (e.g., 0-60 minutes) or within 1-8 hours).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the above-noted disclosure of Batchinsky with the disclosure of Argenbright. The motivation for combining these references would have been to provide proper care of the trauma patient as illustrated by Batchinsky.
Regarding claim 3, Argenbright discloses wherein, to determine the trauma-triage category for the trauma patient, the processing circuitry is configured to select the NEI-6 designation for the trauma patient from a group comprising NEI-6 Positive and NEI-6 Negative ([0003], within 8-24 hrs serves as NEI-6 negative).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the above-noted disclosure of Batchinsky with the disclosure of Argenbright. The motivation for combining these references would have been to provide proper care of the trauma patient as illustrated by Batchinsky.
Regarding claim 5, Argenbright discloses wherein the trauma-triage recommendation indicates recommended levels or types of trauma treatment for the trauma patient ([0003]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the above-noted disclosure of Batchinsky with the disclosure of Argenbright. The motivation for combining these references would have been to provide proper care of the trauma patient as illustrated by Batchinsky.
Claims 15-16 are substantially similar to claims 2-3 and hence rejected on similar grounds.
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Batchinsky et al., US Patent No. 9,532,721 in view of Argenbright et al., US Patent Application No. 2003/0208377 in view of Official Notice (as evidenced by Batchinsky).
Regarding claim 4, Batchinsky and Argenbright disclose the invention as described above. Batchinsky does not disclose the limitations of claim 4. However, Examiner finds the limitations of claim 4, e.g., wherein an NEI-6 Positive designation for the trauma patient indicates that the trauma patient is in need of at least one of the following procedures within 6 hours of an arrival of the trauma patient to an emergency department (ED): receiving 5 or more units of packed red blood cells within four hours of the arrival to the ED; any surgical operation; an angiography; a chest-tube placement; a central-line placement; or a brain-intervention procedure to be old and well-known in the art and hence the Examiner takes Official Notice in this regard.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Batchinsky and Argenbright with the disclosure of Official Notice. The motivation for combining these references would have been to provide proper care of the trauma patient as illustrated by Batchinsky.
In view of Applicant’s traversal of Official Notice (dated 2/10/2025), Examiner cites Batchinsky for disclosing the limitations of claim 4.
Regarding claim 4, Batchinsky discloses wherein an NEI-6 Positive designation for the trauma patient indicates that the trauma patient is in need of at least one of the following procedures within 6 hours of an arrival of the trauma patient to an emergency department (ED): receiving 5 or more units of packed red blood cells within four hours of the arrival to the ED; any surgical operation; an angiography; a chest-tube placement; a central-line placement; or a brain-intervention procedure (claim 1, a chest-tube placement).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Batchinsky and Argenbright with the disclosure of Official Notice. The motivation for combining these references would have been to provide proper care of the trauma patient as illustrated by Batchinsky.
Claim 17 is substantially similar to claim 4 and hence rejected on similar grounds.
Claims 6, 8-10, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Batchinsky et al., US Patent No. 9,532,721 in view of Official Notice (as evidenced by Batchinsky and Travis et al., US Patent Application No. 2021/0241855).
Regarding claims 6, and 8-9, Batchinsky discloses the invention as described above. Batchinsky does not disclose the limitations of claims 6 and 8-9. However, Examiner finds the limitations of claims 6-9, e.g., wherein the plurality of parameters comprise at least: an age of the trauma patient; a gender of the trauma patient; a field Glasgow Coma Scale (GCS) score of the patient; vital signs of the trauma patient; an intentionality of the trauma patient; and a mechanism of an injury of the trauma patient; wherein the one or more machine-learning models comprise one of a logistic-regression model, a boosted-tree model, a boosted-stump model, or a random-forest model; and wherein the one or more machine-learning models comprise the logistic-regression model, and wherein the processing circuitry is further configured to generate and output a basis for the trauma-triage category determined by the logistic-regression model to be old and well-known in the art and hence the Examiner takes Official Notice in this regard.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Batchinsky with the disclosure of Official Notice. The motivation for combining these references would have been to provide proper care of the trauma patient as illustrated by Batchinsky (as evidenced by Batchinsky).
In view of Applicant’s traversal of Official Notice (dated 2/10/2025), Examiner cites Batchinsky for disclosing the limitations of claims 6 and 8-10.
Regarding claim 6, Batchinsky discloses wherein the plurality of parameters comprise at least: an age of the trauma patient; a gender of the trauma patient; a field Glasgow Coma Scale (GCS) score of the patient; vital signs of the trauma patient; an intentionality of the trauma patient; and a mechanism of an injury of the trauma patient (col. 9, line 66-col. 10, line 3; col. 20, lines 35-39; col. 9, line 66-col. 10, line 3).
Travis discloses wherein the one or more machine-learning models comprise one of a logistic-regression model, a boosted-tree model, a boosted-stump model, or a random-forest model; and wherein the one or more machine-learning models comprise the logistic-regression model ([0035]), and wherein the processing circuitry is further configured to generate and output a basis for the trauma-triage category determined by the logistic-regression model ([0035]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the above-noted disclosure of Batchinsky with the disclosure of Official Notice. The motivation for combining these references would have been to provide proper care of the trauma patient as illustrated by Batchinsky (as evidenced by Batchinsky and Travis).
Regarding claim 10, it has been held that a wherein clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim (Texas Instruments Inc. v. International Trade Commission 26, USPQ2d 1010 (Fed. Cir. 1993); Griffin v. Bertina, 62 USPQ2d 1431 (Fed. Cir. 2002); Amazon.com Inc. v. Barnesandnoble.com Inc., 57 USPQ2d 1747 (CAFC 2001)), therefore, wherein, to generate the basis for the trauma-triage category, the processing circuitry is configured to output an indication of a set of coefficients associated with respective parameters of the plurality of parameters will not differentiate the claims from the prior art.
Claim 19 is substantially similar to claim 6 and hence rejected on similar grounds.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Batchinsky et al., US Patent No. 9,532,721 in view of Cardenas et al., US Patent Application No. 2021/0308228.
Regarding claim 18, Cardenas discloses the processing circuitry is further configured to output, for display via the user interface, a recommendation for a full Trauma-Team Activation (TTA) for the trauma patient ([0082]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the above-noted disclosure of Batchinsky with the disclosure of Cardenas. The motivation for combining these references would have to provide proper care of the trauma patient as illustrated by Batchinsky.
Response to Arguments
Examiner has withdrawn previous 35 U.S.C. 112(b) rejection, however, a new 35 U.S.C. 112(b) rejection based on the amendment has been introduced in this office action.
Applicant's arguments filed dated 12/4/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-11 and 13-20 under 35 U.S.C. 101, Applicant states that under Step 2A, Prong 2, claim 1 explicitly describes features that enable a technological solution to the problem of incomplete patient data. Indeed, claim 1 recites particular techniques that enable a system to determine a trauma-triage category for the patient even if there is a missing parameter from the user input, which enables the system, to determine a trauma-triage category by calculating a default value for the missing parameter and imputing the default value to generate a complete parameter set for the patient by the medical technology.
Examiner respectfully disagrees and notes that calculating and assigning a default value to a missing parameter makes use of average value of the one or more missing parameters calculated from the set of training data. Calculating an average value and then using the average value to determine a trauma-triage category is a mere mathematical concept which is an abstract concept. It is not a technical solution at all since the additional elements are simply present to apply the abstract idea. Determining a trauma-triage category is an abstract concept as identified above and using average value for the missing parameters to determine a trauma-triage category does not transform an abstract idea into a patent eligible subject matter. Thus, these arguments are not persuasive.
With respect to Applicant’s arguments regarding Step 2B, Examiner notes that a specific way of identifying and correcting an incomplete data set for determining a trauma-triage category for a patient involves averaging the value of one or more missing parameters which does not provide an inventive concept as averaging involves mathematical concept and are abstract in nature. Thus, these arguments are not persuasive.
With respect to the rejection of independent clams 1, 14, and 20 and dependent claims 2-13, 15, and 17-19 under U.S.C. 103, Applicant’s arguments are moot in view of new grounds of rejection presented above in this office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684