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 .
Claim Objections
Claim(s) 10, 12 is/are objected to because of the following informalities:
In claim 10, line(s) 7, “different countries ; and” seems to be a grammatical error. Examiner recommends amending it to read -- different countries[[ ]]; and --.
In claim 12, line(s) 3, “for each item” seems to be a grammatical error. Examiner recommends amending it to read -- for the item --.
Appropriate correction is required.
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.
Claim(s) 4, 6, 10 is/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.
Claims 4, 6 recites “wherein the editing level is such that an item of low priority in the…medical data after the second editing process has a lower accuracy than that item in the medical data before the second editing process.” It is unclear if “that item in the medical data before the second editing process” is an accuracy, or a value, such that that the “item of low priority…has a lower accuracy than that item”; or if “that item in the medical data before the second editing process” has a higher accuracy than “an item of low priority in the…medical data after the second editing process,” such that the claims read: “wherein the editing level is such that an item of low priority in the…medical data after the second editing process is less accurate than an item in the medical data before the second editing process”? Per broadest reasonable interpretation in light of the specification, “accuracy” means “how close a measured or computed value is to the true, real, or accepted value.” However, what is “the true, real, or accepted value” relative to the measurement of the claimed accuracy? How is the accuracy related to the editing level? If the aforementioned items are different, Examiner recommends numbering the different items (i.e., first, second, etc. item). Appropriate clarification is requested for the proper interpretation of the claim limitations, as the ambiguity renders the metes and bounds of the claim unclear.
Claim 10 recites “in a case where the intended use is the same.” It is unclear as to what “the intended use is the same.” There is only one “intended use” and thus, it is unclear what the frame of reference is. Appropriate clarification is requested for the proper interpretation of the claim limitations, as the ambiguity renders the metes and bounds of the claim unclear.
Claim 10 recites “in a case where the intended use is the same and the output source and the output destination of the medical data are in the same country, define that state as having a standard editing level, set the editing level higher than the standard editing level in a state in which the output source and the output destination are in different countries ; and set the editing level lower than the standard editing level in a state in which the output source and the output destination are in the same country and are related institutions.” However, it is unclear if Applicant intends for “state” to mean “an organized political community living under a single government within a defined territory,” which is relevant to the aforementioned countries; or if Applicant intends for “state” to mean “mode or condition of being,” such that the claims further recite conditional limitations. Appropriate clarification is requested for the proper interpretation of the claim limitations, as the ambiguity renders the metes and bounds of the claim unclear. Examiner notes: Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
The terms “higher” and “lower” in claim 10 is a relative term which renders the claim indefinite. The terms “higher” and “lower” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. How is an editing level measured, such that one is considered “higher” and “lower” than another? Appropriate clarification is requested for the proper interpretation of the claim limitations, as the ambiguity renders the metes and bounds of the claim unclear.
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.
Claim(s) 1-15 is/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. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 1 is drawn to an apparatus which is within the four statutory categories (i.e., machine). Claim 13 is drawn to a non-transitory computer readable mediumwhich is within the four statutory categories (i.e., manufacture). Claim 14 is drawn to a method which is within the four statutory categories (i.e., method).
Independent claim 1 (which is representative of independent claims 13-14) recites…perform a first editing process on medical data including personal information and health data of an individual, the first editing process editing an item of the personal information that is capable of identifying the individual; and perform a second editing process on the medical data after the first editing process in accordance with an editing level according to an output destination.
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to analyze data and provide an output (i.e., edited data) accordingly in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps as indicated supra. That is, other than reciting generic computer components (discussed infra), the claim amounts to managing personal behavior or relationships or interactions between people following rules or instructions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 1 recites additional elements (i.e., A medical data management apparatus comprising a processor). Claim 13 recites additional elements (i.e., A non-transitory computer readable medium for storing a medical data management program; a computer). Looking to the specifications, a computing device having a processor, non-transitory computer readable medium storing a program is described at a high level of generality (¶ 0027; ¶ 0081; ¶ 0086), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. 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.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a computing device having a processor, non-transitory computer readable medium storing a program) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-12, 15 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 2-7, 9-12 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claim 8 further recites the additional elements of “a user interface,” which is only invoked merely as a tool in its ordinary capacity to perform an existing process (i.e., receiving, providing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, and only generally links the claimed invention to a particular technological environment or field of use (i.e., computer technology), which does not impose meaningful limits on the scope of the claim. Also, functional limitations further define the analysis and organization of data for the performance of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claim 15 further recites the additional elements of “a step of transmitting the medical data, after the first editing process and before the second editing process, from a server of the facility on the provision side of the medical data to a server of the facility on the use side of the medical data,” which only invokes the servers merely as a tool in its ordinary capacity to perform an existing process (i.e., receiving, providing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, and only provides the input data for the performance of the abstract idea, and as such, amounts to insignificant extrasolution activity (i.e., mere data gathering), which does not impose meaningful limits on the scope of the claim. Also, functional limitations further define the analysis and organization of data for the performance of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application. Reevaluated under step 2B, “a step of transmitting the medical data, after the first editing process and before the second editing process, from a server of the facility on the provision side of the medical data to a server of the facility on the use side of the medical data” still only invokes the servers merely as a tool in its ordinary capacity to perform an existing process (i.e., receiving, providing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, which does not impose meaningful limits on the scope of the claim. Furthermore, receiving or transmitting data over a network has been recognized by the courts as well-understood, routine, and conventional elements/functions. See: MPEP § 2106.05(d)(II). Also, functional limitations further define the analysis and organization of data for the performance of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea groupings and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-4, 7-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. US 2021/0240853 A1 (hereinafter referred to as "Carlson").
Regarding claim 1, Carlson teaches a medical data management apparatus comprising a processor (Carlson: ¶ 0142),
wherein the processor is configured to:
perform a first editing process on medical data including personal information and health data of an individual (Carlson: ¶ 0149-0150; ¶ 0180), the first editing process editing an item of the personal information that is capable of identifying the individual (Carlson: ¶ 0151, i.e., “The output of de-identification module 564 takes the form of de-identified data 566”; ¶ 0152, i.e., “De-identification module 564 may assign the same pseudo-identifiers (e.g., randomly-generated unique identifiers)…[a patient named “John Smith” was] assigned the pseudo-identifier MRN 7371637”; ¶ 0181); and
perform a second editing process on the medical data after the first editing process in accordance with an editing level according to an output destination (Carlson: ¶ 0161; ¶ 0162, i.e., “The first level of de-identified data 672.sub.1 may itself be further processed (rather than processing the original raw data), e.g., by one or more de-identification modules 102, to generate second level de-identified data 672.sub.2 that is provided to second research entity 670.sub.2. Similarly, the second level of de-identified data 672.sub.2 may itself be further processed, e.g., by one or more de-identification modules 102, to generate third level de-identified data 672.sub.3 that is provided to third research entity 670.sub.3”; ¶ 0183).
Regarding claim 2, Carlson teaches the medical data management apparatus according to claim 1,
wherein the medical data after the first editing process is restorable to the medical data before the first editing process (Carlson: ¶ 0140, i.e., “the processing can be reversed, effectively “re-identifying” the plurality of data points”), and
the editing level is a level at which medical data after the second editing process is restorable to medical data before the second editing process (Carlson: ¶ 0140, i.e., “the processing can be reversed, effectively “re-identifying” the plurality of data points”).
Regarding claim 3, Carlson teaches the medical data management apparatus according to claim 2,
wherein in a case where the second editing process is performed on the medical data after the first editing process at the editing level at which the medical data is restorable, the individual can be identified from the medical data by combining a plurality of pieces of health data after the second editing process (Carlson: ¶ 0140, i.e., “the processing can be reversed, effectively “re-identifying” the plurality of data points. For example, the log may include a two-way mapping between a subject's identifier (e.g., social security number, driver's license number, etc.) and a unique identifier generated therefrom”).
Regarding claim 4, Carlson teaches the medical data management apparatus according to claim 3,
wherein the editing level is such that an item of low priority in the restorable medical data after the second editing process has a lower accuracy than that item in the medical data before the second editing process (Carlson: ¶ 0183, i.e., Examiner interprets this limitation as not patentably distinguishing the claimed invention from the cited prior art because “The resulting second de-identified data may lack at least another of the plurality of identifying features mentioned previously, in addition to those identifying feature(s) that were already addressed at block 1004” and all items in the restorable medical data after the second editing process is less close to their original values after the second editing process, which means they have the claimed “lower accuracy”).
Regarding claim 7, Carlson teaches the medical data management apparatus according to claim 1,
wherein the processor is configured to:
set the editing level with reference to a conversion table in which the output destination and the editing level are associated with each other (Carlson: ¶ 0054, i.e., “internal (“id:int”) identifiers will be mapped to handlers, e.g., by PHI transformer 104, using a lookup table”; ¶ 0055, i.e., “a library of handlers may be maintained, e.g., by PHI transformer 104…The following sub-sections list non-limiting examples of policies, each including a policy name (in quotes), description, and input, output, and configuration options of each policy handler”; ¶ 0131).
Regarding claim 8, Carlson teaches the medical data management apparatus according to claim 7,
wherein the conversion table is set or updated by a user interface (Carlson: ¶ 0043, i.e., “users are able to customize and/or create new policies and/or handlers to deal with various types of data as needed”; ¶ 0170).
Regarding claim 9, Carlson teaches the medical data management apparatus according to claim 8,
wherein the editing level is switched between a restorable level and a non-restorable level according to an intended use of the output destination (Carlson: ¶ 0184; ¶ 0185, i.e., “distribute data that is de-identified at any number of levels to any number of outside entities… it is possible to generate and distribute more heavily de-identified data first (e.g., to the second outside entity), and then later re-identify at least part of the second de-identified data (if necessary) to generate the first de-identified data for the first outside entity”).
Regarding claim 10, Carlson teaches the medical data management apparatus according to claim 9,
wherein the processor is configured to:
in a case where the intended use is the same and the output source and the output destination of the medical data are in the same country, define that state as having a standard editing level (Carlson: ¶ 0161, i.e., “first research entity 670.sub.1 might operate under the constraints imposed by HIPAA…the de-identification requirements imposed on first research entity 670.sub.1 are the least restrictive (e.g., it is a relatively highly trusted entity such as a government agency for which a strength of its security measures are known”),
set the editing level higher than the standard editing level in a state in which the output source and the output destination are in different countries (Carlson: ¶ 0161, i.e., “Second research entity 670.sub.2 might operate under different regulations, e.g., imposed by a government or agency outside of the United States…the de-identification requirements imposed on second research entity 670.sub.2 are more restrictive”); and
set the editing level lower than the standard editing level in a state in which the output source and the output destination are in the same country and are related institutions (Carlson: ¶ 0165, i.e., “a re-identification module 765 may be configured to retrieve de-identified data from the cloud storage/processing infrastructure, e.g., for use by one or more clinical applications 767 operating at hospital 560, and re-identify the data to its original form (e.g., using a persisted PHI lookup table). For example, clinical application 767 may be a CDS application that helps medical personnel make decisions based on re-identified data”).
Regarding claim 11, Carlson teaches the medical data management apparatus according to claim 1,
wherein the processor is configured to:
in the second editing process, perform a process of reducing the accuracy of information, for an item indicating a rare disease (Carlson: ¶ 0183, i.e., Examiner interprets this limitation as not patentably distinguishing the claimed invention from the cited prior art because “The resulting second de-identified data may lack at least another of the plurality of identifying features mentioned previously, in addition to those identifying feature(s) that were already addressed at block 1004” and all items in the restorable medical data after the second editing process is changed to become less close to their original values after the second editing process, which means the “accuracy of information” has been reduced).
Regarding claim 12, Carlson teaches the medical data management apparatus according to claim 1,
wherein in a case where the medical data includes a medical image, the personal information includes personal identification information determined for each item and personal image information for identifying the individual from the medical image (Carlson: ¶ 0149-0150; ¶ 0152; ¶ 0175).
Regarding claim 13, claim 13 recites substantially similar limitations analogous to those already addressed in claim 1, and thus, claim 13 is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Regarding claim 14, claim 14 recites substantially similar limitations analogous to those already addressed in claim 1, and thus, claim 14 is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Regarding claim 15, Carlson teaches a medical data management method according to claim 14,
wherein a facility that performs the first editing process is a facility on a provision side of the medical data (Carlson: figure 5, i.e., “De-identification” module 564 provides data to “Data security officer” 568; ¶ 0151), and a facility that performs the second editing process is a facility on a use side of the medical data (Carlson: figure 5, i.e., “Data security officer” 568 is outside of the environment of the hospital 560 and uses data for further “Research” 562; ¶ 0151), and
the method further comprises:
a step of transmitting the medical data, after the first editing process and before the second editing process, from a server of the facility on the provision side of the medical data to a server of the facility on the use side of the medical data (Carlson: figure 5, i.e., “De-identified data” 566 is transmitted from “De-identification” module 564 to “Data security officer” 568, as noted by the one-way arrows; ¶ 0151).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. US 2021/0240853 A1 (hereinafter referred to as "Carlson") in view of U.S. Patent App. Pub. No. US 2022/0019687 A1 (hereinafter referred to as "Poutra").
Regarding claim 5, Carlson teaches the medical data management apparatus according to claim 1,
wherein the medical data after the first editing process is restorable to the medical data before the first editing process (Carlson: ¶ 0140, i.e., “the processing can be reversed, effectively “re-identifying” the plurality of data points”)…
Yet, Carlson does not explicitly teach, but Poutra teaches, in the same field of endeavor,
the editing level is a level at which medical data after the second editing process is non-restorable to medical data before the second editing process (Poutra: ¶ 0025, i.e., “after the anonymization/pseudonymization, the original field value cannot be recovered by reverse engineering”).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the editing level is a level at which medical data after the second editing process is non-restorable to medical data before the second editing process, as taught by Poutra, within the system of Carlson, with the motivation of “there is no need to maintain keys to restore the data as one would with encryption or tokenization where the original data may be recovered” (Poutra: ¶ 0008).
Regarding claim 6, Carlson and Poutra teach the medical data management apparatus according to claim 5,
wherein the editing level is such that an item of low priority in the non-restorable medical data after the second editing process has a lower accuracy than that item in the medical data before the second editing process (Poutra: ¶ 0025, i.e., Examiner interprets this limitation as not patentably distinguishing the claimed invention from the cited prior art because “after the anonymization/pseudonymization, the original field value cannot be recovered by reverse engineering” and all items in the non-restorable medical data after the second editing process is less close to their original values after the second editing process, which means they have the claimed “lower accuracy”).
The obviousness of combining the teachings of Carlson and Poutra are discussed in the rejection of claim 5, and incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2023/0169211 A1 teaches de-identifying patient data from medical reports and diagnostic images, while preserving the ability for the data to be re-identified.
WO 2020/106588 A1 teaches de-identifying and re-identifying DICOM data based on the endpoint for the archival of the modified data.
“HIDE: An Integrated System for Health Information DE-identification” teaches deploying a conditional random fields based technique for extracting identifying attributes from unstructured data and k-anonymization based technique for de-identifying the data while preserving maximum data utility.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571) 272-8317. The examiner can normally be reached on M-Th 7-4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY HUYNH/Primary Examiner, Art Unit 3683
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