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 .
Status of Application
This action is in reply to the reply received March 20, 2026 (hereinafter “Reply”).
Claims 1-3, 10, and 11 are amended.
Claim 8 is cancelled.
Claim 12 is new.
Claims 1-7 and 9-12 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, applicant cannot rely upon the certified copy of the foreign priority application to overcome prior art rejections because a translation of said application has not been made of record in accordance with 37 C.F.R. § 1.55. See M.P.E.P. §§ 215 and 216.
Claim Rejections - 35 U.S.C. § 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 9-12 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to non-statutory subject matter. Claims 1-11 are directed to an abstract idea without significantly more as required by the Alice test as discussed below.
Step 1
Claims 1-7 and 9-12 are directed to a process, machine, manufacture, or composition of matter.
Step 2A
Claims 1-7 and 9-12 are directed to abstract ideas, as explained below.
Prong one of the Step 2A analysis requires identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea; and determining whether the identified limitation(s) falls within at least one of the groupings of abstract ideas of mathematical concepts, mental processes, and certain methods of organizing human activity.
The claims recite the following limitations, which are identified as being directed to abstract ideas. Claim 1 recites receive an input of request information to request for an output of pseudo health data wherein the request information includes attribute information of a person and an indicator of a health issue of the person; [input] the request information to a learning model which is trained using actual health data including the attribute information; and output, from the learning model, pseudo health data, in which the at least one piece of the attributed information is pseudo-generated, in response to the input of the request information requested by a user among a plurality of pieces of information. Claims 10 and 11 recite similar features as claim 1. Claims 2-7, 9, and 12 further specify features of these identified abstract ideas or characteristics of the data used thereby.
These limitations describe abstract ideas that correspond to concepts identified as abstract ideas by the courts as mental processes—such as concepts performed in the human mind (including an observation, evaluation, judgment, or opinion)—because the claimed features identified above are concepts performed in the human mind (including an observation, evaluation, judgment, or opinion).
These limitations describe abstract ideas that correspond to concepts identified as abstract ideas by the courts as certain methods of organizing human activity—such as fundamental economic principles or practices (including hedging, insurance, mitigating risk), commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations), managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)—because the claimed features identified above manage personal behavior or relationships or interactions between people including following rules or instructions.
Thus, the concepts set forth in claims 1-7 and 9-12 recite abstract ideas.
Prong two of the Step 2A requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. Further, “integration into a practical application” uses the considerations laid out by the Supreme Court and the Federal Circuit to evaluate whether the judicial exception is integrated into a practical application, such as considerations discussed in M.P.E.P. § 2106.05(a)-(h).
The claims recite the following additional elements beyond those identified above as being directed to an abstract idea. Claim 1 recites a terminal device, a processor, transmitting the request information, output pseudo health data, and notifying the data to the user. Claim 10 recites similar features as claim 1. Claim 11 recites similar features as claim 1 and further recites a non-transitory computer readable medium. Several dependent claims recite features for receiving a selection from a user and other input and output operations, as well as displaying or transmitting other information. Insofar as the transmitting and outputting operations actually require computer implementation (which is not the case in all instances), these features are considered as additional elements. Claim 12 further recites a checkbox.
The identified judicial exception(s) are not integrated into a practical application for the following reasons.
First, evaluated individually, the additional elements do not integrate the identified abstract ideas into a practical application. The additional computer elements identified above—the terminal device, processor, non-transitory computer readable medium, and display including a checkbox—are recited at a high level of generality. Inclusion of these elements amounts to mere instructions to implement the identified abstract ideas on a computer. See M.P.E.P. § 2106.05(f). The use of conventional computer elements to transmit/output/notify/display data or to receive it (e.g., via a selection using, for example, a checkbox) is the insignificant, extra-solution activity of mere data gathering or outputting in conjunction with a law of nature or abstract idea. See M.P.E.P. § 2106.05(g). To the extent that the claims transform data, the mere manipulation of data is not a transformation. See M.P.E.P. § 2106.05(c). Inclusion of the computing system in the claims amounts to generally linking the use of the judicial exception to a particular technological environment or field of use. See M.P.E.P. § 2106.05(h). Thus, taken alone, the additional elements do not amount to significantly more than a judicial exception.
Second, evaluating the claim 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. See M.P.E.P. § 2106.05(a). Their collective functions merely provide an implementation of the identified abstract ideas on a computer system in the general field of use of anonymizing health information. See M.P.E.P. § 2106.05(h).
Thus, claims 1-7 and 9-12 recite mathematical concepts, mental processes, or certain methods of organizing human activity without including additional elements that integrate the exception into a practical application of the exception.
Accordingly, claims 1-7 and 9-12 are directed to abstract ideas.
Step 2B
Claims 1-7 and 9-12 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, when considered both individually and as an ordered combination, do not amount to significantly more than the abstract idea.
The analysis above describes how the claims recite the additional elements beyond those identified above as being directed to an abstract idea, as well as why identified judicial exception(s) are not integrated into a practical application. These findings are hereby incorporated into the analysis of the additional elements when considered both individually and in combination. Additional features of these analyses are discussed below.
Evaluated individually, the additional elements do not amount to significantly more than a judicial exception. In addition to the factors discussed regarding Step 2A, prong two, these additional computer elements also provide conventional computer functions that do not add meaningful limits to practicing the abstract idea. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to transmit/output/notify/display data or to receive it (e.g., via a selection of, for example, a checkbox) is the well-understood, routine, and conventional computer functions of receiving or transmitting data over a network, e.g., the Internet, and does not impose any meaningful limit on the computer implementation of the identified abstract ideas. See M.P.E.P. § 2106.05(d)(II). Thus, taken alone, the additional elements do not amount to significantly more than a judicial exception.
Evaluating the claim limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. In addition to the factors discussed regarding Step 2A, prong two, there is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely amount to mere instructions to implement the identified abstract ideas on a computer.
Thus, claims 1-7 and 9-12, taken individually and as an ordered combination of elements, are not directed to eligible subject matter since they are directed to an abstract idea without significantly more.
Claim Rejections - 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 10, and 11 are rejected under 35 U.S.C. § 102(a)(1)-(2) as being anticipated by Stalling et al. (U.S. Pub. No. 2017/0032084 A1) (hereinafter “Stalling”).
Claims 1, 10, and 11: Stalling, as shown, discloses the following limitations:
a processor (see at least ¶ [0132]: a system comprises at least a first client digital data processor, an anonymization program and a server digital data processor, the server digital data processor in communications coupling with the first client digital data processor, the server digital data processor responding to a request from the first client digital data processor to export one or more medical diagnostic reports; see also at least ¶¶ [0133]-[0140]),
wherein the processor is configured to:
receive, from a user terminal device, an input request of information to request for an output of pseudo health data wherein the request information includes attribute information of a person and an indicator of a health issue of the person (see at least ¶ [0090]: the server digital data processor including an anonymization program, executing on the server digital data processor, the anonymization program responding to a request from a first client on a first client digital data processor of the one or more client digital data processors by executing one or more anonymization commands, comprising the steps of receiving one or more medical diagnostic reports designated by the first client, retrieving one or more phi of metadata containing protected health information in the one or more medical reports; see also at least ¶ [0077]: FIG. 3A shows an artist’s impression of a dialog for exporting an exam. The dialog offers a De-Identification option. Clicking the Details button allows to configure the De-Identification. FIG. 3B shows an artist’s impression of the dialog to configure the De-Identification details. Default values are filled in, depending on the system configuration. Note that in various embodiments of the invention, the fields that are affected by the anonymization may vary from system to system based on the exact use-case, the jurisdiction, changes in the Health Insurance Portability and Accountability Act (HIPAA), changes in other laws effecting the HIPAA regulations or other parameters. Accordingly, in various embodiments of the invention, the list can be configurable; see also at least ¶ [0078]: FIG. 7A shows a dialog for exporting an exam with a De-Identification option, according to an embodiment of the invention. FIG. 7B shows the dialog to configure the De-Identification details, according to an embodiment of the invention);
transmit the request information to a learning model which is trained using actual health data including the attribute information (see at least ¶¶ [0077]-[0078] and [0090] and the analysis above. User or system configuration of the deidentification rules (as well as alterations thereof) reflects training of a learning model that uses the actual health data. Further, alterations of the configure demonstrate that the system is a learning model);
output, from the learning model, pseudo health data, in which at least one piece of information of the attribute information is pseudo-generated, in response to the input of the request information requested by a user among a plurality of pieces of information (see at least ¶ [0038]: the term ‘anonymization’ means to remove the possibility of ascertaining protected health information values from a medical diagnostic report; see also at least ¶ [0054]: the phrase ‘pseudo-Patient Identifiable Information’ or ‘pseudo-PII’ means information that is used to simulate PII or PHI. Pseudo-PII does not and cannot function as PII or PHI. Pseudo-PII appears in the same format as PII or PHI, but because it is simulated it cannot be used on its own or with other information to identify, contact, locate or identify: a patient, a health status, a provision of health care or a payment for health care; see also at least ¶ [0075]: specific information is not displayed and replaced by “*****” in the anonymized medical report when viewed in the teaching mode. On the top left in FIG. 2 the ‘Patient Name’ is *****, the ‘Patient ID’ is replaced with ‘AnonID’ which is f59c4a5c*****.76Y, the ‘Exam ID’ is *****, the ‘Study (Exam) Description’ remains THORAX AP, and the ‘Study Date’ is *****. On the top right, FIG. 2 does not show the ‘Hospital Name’, but still shows the ‘Imaging Device Name’ as KODAK Elite CR, and the ‘Physician's Name’ is *****. Further, FIG. 2 shows on the lower left the ‘Imaging Orientation’ as AP, the ‘Acquisition Time’ is *****, and the ‘Series/Image number’ as 1 IMA 2. The Patient Birth Day is removed, but the patient's age (in years) is shown as 76Y; see also at least ¶ [0077]: the fields that are affected by the anonymization may vary from system to system based on the exact use-case, the jurisdiction, changes in the Health Insurance Portability and Accountability Act (HIPAA), changes in other laws effecting the HIPAA regulations or other parameters; see also at least ¶¶ [0025], [0077]-[0078], and [0090]); and
notify the pseudo health data to the user terminal device (see at least ¶ [0078]: FIG. 5 shows the medical report with pseudo-PII identified in FIG. 1, according to an embodiment of the invention. FIG. 6 shows the medical report shown in FIG. 5 (see FIG. 2 for artist's impression) after anonymization in teaching mode, according to an embodiment of the invention. FIG. 7A shows a dialog for exporting an exam with a De-Identification option, according to an embodiment of the invention. FIG. 7B shows the dialog to configure the De-Identification details, according to an embodiment of the invention. FIG. 8 shows the medical report shown in FIG. 5 after export using the anonymization settings shown in FIG. 7B, according to an embodiment of the invention; see also at least ¶¶ [0025], [0038], [0054], [0075], and [0077]).
Claim 2: Stalling discloses the limitations as shown in the rejections above. Further, Stalling, as shown, discloses the following limitations:
wherein in the pseudo health data, all information other than the request information is pseudo-generated (see at least ¶ [0054]: the phrase ‘pseudo-Patient Identifiable Information’ or ‘pseudo-PII’ means information that is used to simulate PII or PHI. Pseudo-PII does not and cannot function as PII or PHI. Pseudo-PII appears in the same format as PII or PHI, but because it is simulated it cannot be used on its own or with other information to identify, contact, locate or identify: a patient, a health status, a provision of health care or a payment for health care. Pseudo-PII rather than PII or PHI is displayed in this application in accordance with HIPAA, The Privacy Act, ARRA, COPPA, FERPA, FCRA, GLBA and HITECH to exemplify PII or PHI and the invention is applied to this pseudo-PII rather than to PII or PHI. Because the pseudo PII is in a similar format to the PII or PHI, the pseudo-PII can be used to exemplify the anonymization of PII or PHI; see also at least ¶ [0085]: another scenario is the demonstration of clinical cases inside the organization, i.e. without any data export, but where not everybody in the audience might be entitled to see the PII, e.g. a lecture for students. Instead of creating anonymized copies in this case, the present invention allows on-the-fly anonymization. This saves significant amounts of time in educational institutions, such as university hospitals; see also at least ¶¶ [0025], [0038], [0054], [0075], and [0077]).
Claim 3: Stalling discloses the limitations as shown in the rejections above. Further, Stalling, as shown, discloses the following limitations:
wherein the processor is configured to:
receive selection of the pseudo health data by the user (see at least ¶ [0052]: the phrase ‘displaying a listing’ or ‘listing’ means displaying a code or other abbreviated representation of a medical diagnostic report such that it can be selected, where displaying the listing does not display or otherwise access the information contained in the medical diagnostic report. Displaying the listing can be used to select the medical diagnostic report for viewing or other access; see also at least ¶ [0054]); and
extract actual health data that corresponds to the selected pseudo health data from among a plurality of pieces of the actual health data (see at least ¶ [0052]; see also at least ¶ [0064]: this can be tackled by storing a table that maps real patient-identifiers to anonymized ones. This process is often referred to as ‘pseudonymization’. Pseudonymization allows for re-identification of the anonymized data; see also at least ¶ [0077]: FIG. 3B shows an artist's impression of the dialog to configure the De-Identification details. Default values are filled in, depending on the system configuration. Note that in various embodiments of the invention, the fields that are affected by the anonymization may vary from system to system; see also at least ¶¶ [0054] and [0078]).
Claim 4: Stalling discloses the limitations as shown in the rejections above. Further, Stalling, as shown, discloses the following limitations:
wherein the processor is configured to notify a request for use permission to an examinee of the actual health data (see at least ¶ [0052]: the phrase ‘displaying a listing’ or ‘listing’ means displaying a code or other abbreviated representation of a medical diagnostic report such that it can be selected, where displaying the listing does not display or otherwise access the information contained in the medical diagnostic report. Displaying the listing can be used to select the medical diagnostic report for viewing or other access; see also at least ¶ [0064]: this can be tackled by storing a table that maps real patient-identifiers to anonymized ones. This process is often referred to as ‘pseudonymization’. Pseudonymization allows for re-identification of the anonymized data; see also at least ¶ [0077]: FIG. 3B shows an artist's impression of the dialog to configure the De-Identification details. Default values are filled in, depending on the system configuration. Note that in various embodiments of the invention, the fields that are affected by the anonymization may vary from system to system; see also at least ¶¶ [0054] and [0078]).
Claim 5: Stalling discloses the limitations as shown in the rejections above. Further, Stalling, as shown, discloses the following limitations:
wherein the processor is configured to control whether the actual health data is extracted by referring to a storage unit that stores the pseudo health data in association with the user (see at least ¶ [0052]: the phrase ‘displaying a listing’ or ‘listing’ means displaying a code or other abbreviated representation of a medical diagnostic report such that it can be selected, where displaying the listing does not display or otherwise access the information contained in the medical diagnostic report. Displaying the listing can be used to select the medical diagnostic report for viewing or other access; see also at least ¶ [0064]: this can be tackled by storing a table that maps real patient-identifiers to anonymized ones. This process is often referred to as ‘pseudonymization’. Pseudonymization allows for re-identification of the anonymized data; see also at least ¶ [0077]: FIG. 3B shows an artist's impression of the dialog to configure the De-Identification details. Default values are filled in, depending on the system configuration. Note that in various embodiments of the invention, the fields that are affected by the anonymization may vary from system to system; see also at least ¶¶ [0054] and [0078]).
Claim 6: Stalling discloses the limitations as shown in the rejections above. Further, Stalling, as shown, discloses the following limitations:
wherein the processor is configured to:
extract the actual health data in a case where the pseudo health data is selected by the user in the storage unit (see at least ¶ [0052]: the phrase ‘displaying a listing’ or ‘listing’ means displaying a code or other abbreviated representation of a medical diagnostic report such that it can be selected, where displaying the listing does not display or otherwise access the information contained in the medical diagnostic report. Displaying the listing can be used to select the medical diagnostic report for viewing or other access; see also at least ¶ [0064]: this can be tackled by storing a table that maps real patient-identifiers to anonymized ones. This process is often referred to as ‘pseudonymization’. Pseudonymization allows for re-identification of the anonymized data; see also at least ¶ [0077]: FIG. 3B shows an artist's impression of the dialog to configure the De-Identification details. Default values are filled in, depending on the system configuration. Note that in various embodiments of the invention, the fields that are affected by the anonymization may vary from system to system; see also at least ¶¶ [0054] and [0078]); and
does not extract the actual health data in a case where the pseudo health data is selected by a user who is not associated with the pseudo health data in the storage unit (see at least ¶ [0051]: the phrase ‘user ID’ refers to the access permissions associated with an individual use; see also at least ¶ [0052]: phrase ‘displaying a listing’ or ‘listing’ means displaying a code or other abbreviated representation of a medical diagnostic report such that it can be selected, where displaying the listing does not display or otherwise access the information contained in the medical diagnostic report; see also at least ¶ [0086]: a user based on their user ID can start the client application of the clinical software system in a dedicated presentation mode. In an alternative embodiment of the present invention, a user based on their user ID can turn on a presentation mode so that from that point onwards information displayed on the screen that contains PII is replaced with the mapped values. Often, presentations are prepared by adding relevant cases to a worklist. However, it is also possible to open a case by typing in an original identifier, if the presenter has noted that in his or her preparatory notes. In an embodiment of the present invention, in the ‘Anonymized Presentation Mode’, any PII text fields used for searching will not display the actual characters typed in, but instead just show dots or other replacement characters. In this way the presenter can open relevant cases in front of the audience, e.g. using a video projector, without cumbersome preparatory work, and without disclosing PII. While a student viewing the presentation can make a notation of an output, that output has only value as confirming the output. That is, if after the presentation the student asks the presenter a question about that output, the notation cannot be used to retrieve the presentation. However, if the presenter retrieves the output (by typing in the appropriate input), the output when displayed will have the same notation, and thus confirm that this was the presentation to which the question related).
Claim 7: Stalling discloses the limitations as shown in the rejections above. Further, Stalling, as shown, discloses the following limitations:
wherein the processor is configured to notify a request for use permission to an examinee of the actual health data in a case where the actual health data is extracted (see at least ¶ [0052]: the phrase ‘displaying a listing’ or ‘listing’ means displaying a code or other abbreviated representation of a medical diagnostic report such that it can be selected, where displaying the listing does not display or otherwise access the information contained in the medical diagnostic report. Displaying the listing can be used to select the medical diagnostic report for viewing or other access; see also at least ¶ [0064]: this can be tackled by storing a table that maps real patient-identifiers to anonymized ones. This process is often referred to as ‘pseudonymization’. Pseudonymization allows for re-identification of the anonymized data; see also at least ¶ [0077]: FIG. 3B shows an artist's impression of the dialog to configure the De-Identification details. Default values are filled in, depending on the system configuration. Note that in various embodiments of the invention, the fields that are affected by the anonymization may vary from system to system; see also at least ¶¶ [0054] and [0078]).
Claim 12: Stalling discloses the limitations as shown in the rejections above. Further, Stalling, as shown, discloses the following limitations:
display, on the user terminal device, the pseudo health data including pseudo health data of multiple users and a checkbox for the pseudo health data of each of the multiple users (see at least ¶ [0090]: the server digital data processor including an anonymization program, executing on the server digital data processor, the anonymization program responding to a request from a first client on a first client digital data processor of the one or more client digital data processors by executing one or more anonymization commands, comprising the steps of receiving one or more medical diagnostic reports designated by the first client, retrieving one or more phi of metadata containing protected health information in the one or more medical reports; see also at least ¶ [0077]: FIG. 3A shows an artist’s impression of a dialog for exporting an exam. The dialog offers a De-Identification option. Clicking the Details button allows to configure the De-Identification. FIG. 3B shows an artist’s impression of the dialog to configure the De-Identification details. Default values are filled in, depending on the system configuration. Note that in various embodiments of the invention, the fields that are affected by the anonymization may vary from system to system based on the exact use-case, the jurisdiction, changes in the Health Insurance Portability and Accountability Act (HIPAA), changes in other laws effecting the HIPAA regulations or other parameters. Accordingly, in various embodiments of the invention, the list can be configurable; see also at least ¶ [0078]: FIG. 7A shows a dialog for exporting an exam with a De-Identification option, according to an embodiment of the invention. FIG. 7B shows the dialog to configure the De-Identification details, according to an embodiment of the invention; see also at least ¶ [0081]: computing an institution aware mapped id. In an embodiment of the present invention, the institution name, or another institution identifier is added to the list of input fields to the secure hash function. Examples of suitable identifiers are DICOM tags (0008,0080) or (0010,0021). In this way, the mapped ID will be different for two patients with the same ID coming from two different hospitals; see also at least ¶ [0080]); and
transmit, to a server, a selected pseudo health data corresponding to a checkbox that has been selected (see at least ¶¶ [0077]-[0081] and [0090] and FIGS. 3A-3B and 7A-7B and the analysis thereof above).
Claim Rejections - 35 U.S.C. § 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.
Claim 9 is rejected under AIA 35 U.S.C. § 103 as being unpatentable over Stalling et al. (U.S. Pub. No. 2017/0032084 A1) (hereinafter “Stalling”) in view of Hu et al. (U.S. Pub. No. 2016/0178620 A1) (hereinafter “Hu”).
Claim 9: Stalling discloses the limitations as shown in the rejections above. Further, Stalling, as shown, discloses the following limitations:
wherein the information includes attribute information including at least one of blood pressure, age, blood glucose level, uric acid level, or body weight (see at least ¶ [0025]: the phrase ‘medical diagnostic report’ means a report associated with a medical diagnosis where the medical diagnostic report contains data including protected health information pertaining to the name, age and/or sex of the patient, medical history, physical examination and/or medical diagnosis of the patient, where at least some of the data is computer readable; see also at least ¶ [0075]: FIG. 2 does not show the ‘Hospital Name’, but still shows the ‘Imaging Device Name’ as KODAK Elite CR, and the ‘Physician's Name’ is *****. Further, FIG. 2 shows on the lower left the ‘Imaging Orientation’ as AP, the ‘Acquisition Time’ is *****, and the ‘Series/Image number’ as 1 IMA 2. The Patient Birth Day is removed, but the patient's age (in years) is shown as 76Y).
Although Stalling discloses anonymizing medical diagnostic reports, Stalling does not explicitly disclose, but Hu, as shown, teaches the following information:
[the information] also includes an indicator containing at least one of hypertension, metabolic syndrome, or diabetes (see at least ¶ [0112]: Independent studies were carried out to identify a set of biomarkers that when used with a polynomic algorithm will enable the early detection of changes in insulin resistance in a subject. In one aspect, the instant invention provides the subject with a score indicating the level of insulin resistance (“IR Score”) of the subject. The score is based upon clinically significant changed reference level for a biomarker and/or combination of biomarkers. The reference level can be derived from an algorithm or computed from indices for impaired glucose tolerance and can be presented in a report as shown in FIG. 5. The IR Score places the subject in the range of insulin resistance from normal (i.e. insulin sensitive) to high. Disease progression or remission can be monitored by periodic determination and monitoring of the IR Score. Response to therapeutic intervention can be determined by monitoring the IR Score. The IR Score can also be used to evaluate drug efficacy; see FIG. 5).
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 diagnostic techniques taught by Hu with the health information management systems disclosed by Stalling, because Hu teaches at ¶ [0112] that by using its techniques “Disease progression or remission can be monitored by periodic determination and monitoring of the IR Score. Response to therapeutic intervention can be determined by monitoring the IR Score. The IR Score can also be used to evaluate drug efficacy.” See M.P.E.P. § 2143(I)(G).
Moreover, 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 diagnostic techniques taught by Hu with the health information management systems disclosed by Stalling, because the claimed invention is merely a combination of old elements (the diagnostic techniques taught by Hu and the health information management systems disclosed by Stalling), in the 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. See M.P.E.P. § 2143(I)(A).
Response to Arguments
The arguments submitted with the Reply have been fully considered. The amendments obviate the rejections under § 112(b). The remaining arguments are not persuasive.
Arguments Regarding the Rejections Under 35 U.S.C. § 101
Applicant argues that “the claimed invention is not simply a data management rule or mental activity, but a technical solution based on a specific computing architecture” because of the recitation of the “learning model” in the claims. Reply, p. 9. Applicant also points to an embodiment in the specification that “is trained using a large amount of real data.” Reply, p. 9. Applicant relies on similar arguments when arguing these features are “not routine and conventional.” Reply, p. 9.
Examiner disagrees that the claims reflect an improvement to any technology. As discussed in the rejections, the learning model is identified as part of the identified abstract ideas. The claims do not specify any features of this model (or its use) that require any “specific computing architecture” or characteristics that prevent it from being used or performed “reasonably” by the human mind.
Arguments Regarding the Rejections Under 35 U.S.C. § 102
Applicant argues that the features introduced by the amendments are not disclosed by Stalling because “The technical essence of Stalling is data reduction or masking” but “it does not actually have the ability to ‘generate’ entirely new data content except to obscure or reduce.” Reply, p. 7. Applicant presents similar arguments regarding claim 9. Reply, pp. 7-8.
Examiner disagrees, because the values created—whether a masked, hashed, or otherwise simulated value—is a creation of a different value. Further, applicant appears to be arguing features—i.e., “the ability to ‘generate’ entirely new data content except to obscure or reduce”—that are not recited in or required by the claims.
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.
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The following references have been cited to further show the state of the art with respect to anonymizing health information.
Han (U.S. Pub. No. 2022/0079529 A1) (pseudo-CT generation using a feature regression model);
Gupta et al. (U.S. Pub. No. 2023/0080686 A1) (machine learning modeling to identify sensitive data);
Kaditz et al. (U.S. Pub. No. 2017/0228557 A1) (manipulating obscured content; see particularly ¶ [0080]);
Grubel et al (U.S. Pub. No. 2017/0024581 A1) (PII disclosure detection);
Yagi (U.S. Pub. No. 2022/0374550 A1); and
Chen et al. (“A multi-layer dynamic model for customer experience analytics," in Bell Labs Technical Journal, vol. 18, no. 4, pp. 19-32, March 2014).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christopher Tokarczyk, whose telephone number is 571-272-9594. The examiner can normally be reached Monday-Thursday between 6:00 AM and 4:00 PM Eastern.
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.
/CHRISTOPHER B TOKARCZYK/ Primary Examiner, Art Unit 3687
Prosecution Insights