DETAILED ACTION
Notice of Pre-AIA or AIA Status
1.The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. According to applicant remarks filed on 11/03/2025, Applicant elected Group I, encompassed by claims 1-21,43-54 and 55-73 without traverse.
Claim Rejections - 35 USC § 101
3. 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.
4. Claims 1-21, 43-54 and 55-73 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Independent claims 1, 43 and 55 do fall into one of the four statutory categories of method and system. Nevertheless, the claim still are considered as abstract idea for the following prongs and reasons.
Step 2A Prong One
In Prong One examiners evaluate whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. Claim 1 recites (1.e., sets forth or describes) an abstract idea of: “in response to the patient giving consent to a data access request: configure secure access to the patient’s health record data based on encrypting the stored data with access encryption parameters; and provide the secure access of the data, which, under the broadest reasonable interpretation, are steps that are performed in the human mind. These limitations merely involve accessing a patient’s health records to users with permission/consent. For example, a provider needing access to a patient’s health records may need to request permission to access the records. The patient (owner of the record) have to approve provider access to the patient’s records, which are performed in the human mind with/without need for a computer. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in a human mind but for the recitation of generic computer components, then it falls within the “mental processes” grouping of abstract ideas and can be done manually. Accordingly, the claim recites an abstract idea. Accordingly, the claim 1 recite an abstract idea. Claims 40 and 55 recites similar features and therefore, claims 40 and 55 are also directed to the abstract idea.
Step 2A Prong Two
In Step 2A prong 2, the judicial exception is not integrated into a practical application because the apparatus, processor and memory circuit are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. The claims also recite the additional steps of “storing a patient’s health record data encrypted with storage encryption parameters”;…. and …. “provide secure access to a specific device at location and time”… Claim 40 recites the additional step of “receiving a request to download the patent’s stored heath record”… However, these steps are insignificant extra-solution activity. The receiving and maintaining steps merely involve gathering and storing data to be used by the mental processes recited in the claims. The sending/providing step merely involves transmitting information. Adding insignificant extra-solution activity to the judicial exception is not enough to qualify as “significantly more”. The additional elements or steps do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Step 2B
Step 2B determines whether the claim as a whole amount to significantly more than the exception itself. Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. Here, the additional elements, taken individually and in combination, do not result in claim 1, as a whole, amounting to significantly more than the judicial exception. As discussed previously with respect to Step 2A, the additional elements merely serve as a tool to perform an abstract idea and generally link the use of the judicial exception to a particular technological environment. Thus, there is no inventive concept in the claim and thus the claim is not eligible, warranting a rejection for lack of subject matter eligibility and concluding the eligibility analysis.
Regarding claims 2-21, claims 44-54 and 56-73 recite the elements “storing…”, “sending…”,… “downloading..,”.. “uploading..”,…sharing…”, “deleting…”,… “accessing…” and “revoking”. However, these features do not add meaningful limitation to the abstract idea because they are mere collections of data, mental processes (download, upload, share, delete, access and revoke) and extra-solution activity (storing and sending).
The elements recited in claims 1-21, 43-54 and 55- 73 when considered individually or in an ordered combination, fail to amount to significantly more than the abstract idea. Accordingly, claims 1-21, 43-54 and 55- 73 are not eligible.
Claim Rejections - 35 USC § 102
5. 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.
6. Claim(s) 1-4,6, 14-21,43-58,60 and 68-72 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mishra (US Pub.No.2016/0103963)
7. Regarding claims 1 and 55 Mishra teaches an apparatus and a method comprising: a processor; and a memory that is not a transitory propagating signal, the memory configured to be operably connected to the processor and including computer readable instructions, including processor executable program instructions, the computer readable instructions accessible to the processor, wherein the processor executable instructions, when executed by the processor, cause the processor to perform operations comprising: store a patient’s health record data encrypted with storage encryption parameters (Fig.5, Para:0104, Para:0109 and Para:0137 teaches patient data such as health records and personal health information may be stored in encrypted form on a storage device or centralized databases),
and in response to the patient giving consent to a data access request: configure secure access to the patient’s health record data based on encrypting the stored data with access encryption parameters distinct from the storage encryption (Para:0108 teaches a request from a user to transfer records may be considered to include consent of the record owner, based on prior identification and/or authentication of the identity of the user as the record holder. The record owner may be presented with a request to confirm transfer request. The request for confirmation may include a request for identification and/or a request to authenticate the identity of the recipient of the transfer request. The consent may be limited to a subset of the owner's Electronic Health Records (EHRs) record.
Para:0137-0138 teaches prior to transmission, the encrypted data may be first decrypted using the local cryptographic key of the sending device. The decrypted data may then be encrypted using a cryptographic key, known to both sender, and receiver and that is created dynamically to exist only during the lifetime of the communication session. The Diffie-Hellman algorithm may be used to create a communication session cryptographic key in such a way that only the two mobile devices 502 and 508 know the key. When encrypted data is received at the destination device 508 or 502, it can be decrypted using the key associated with current proximity exchange and then re-encrypted using the local cryptographic key of the destination device before it is stored).
parameters and provide the secure access to a specific device at a location and time related to the request (Para:0125-0126 and Para:0112 teaches records will not be exchanged without a positive identification of the recipient. When the record holder and the healthcare provider are located in different physical locations, a location identification made by one or more of the record holder and the healthcare provider using one or more of a global positioning system and location information provided by a wireless network. For example, certain wireless network telecommunications services can provide accurate positional information based on triangulation and/or certain signaling characteristics of mobile devices. An authentication or other service may be used to verify identity of, and subsequently connect a record holder and a healthcare provider when the parties are located different physical locations. Para:0147 teaches the record owner will also provide time-limited consent to permit a provider to request and access patient records).
8. Regarding claims 2 and 56 Mishra teaches the apparatus and the method, wherein the data access request further comprises a data upload operation request (Para:0176-0177 teaches the data access request comprises the data upload request)
9. Regarding claims 3 and 57 Mishra teaches the apparatus and the method, wherein the data access request further comprises a data download operation request (Para:0176-0177 teaches the data access request comprises the data download request)
10. Regarding claims 4 and 58 Mishra teaches the apparatus and the method, wherein the data access request further comprises a data share operation request (Para:0127 teaches the data access comprises the data share request).
11. Regarding claims 6 and 60 Mishra teaches the apparatus and the method, wherein provide the secure access further comprises implement the data operation request (Para:0108 teaches provide the secure access comprises data operation request).
12. Regarding claims 14 and 68 Mishra teaches the apparatus and the method, wherein provide the secure access further comprises send a digital message comprising a response to the data access request (Mishra: Para:0095 the electronic health records (EHRs) will be in digital format.
Para:0111-0112 teaches response to the data access request) .
13. Regarding claims 15 and 69 Mishra teaches the apparatus and the method, wherein the response further comprises consent to the data access request (Para:0108-0109 and Para:0147 teaches consent to the data access request).
14. Regarding claims 16 and 70 Mishra teaches the apparatus and the method, wherein the response further comprises denial to the data access request (Para:0111-0112 teaches the records will not be exchanged without a positive identification of the recipient i.e., denial to the data access request).
15. Regarding claims 17 and 71 Mishra teaches the apparatus and the method, wherein the response is determined as a function of the data access requestor’s identity authenticated based on sensor data (Para:0110-0112 and Para:0125 teaches verifying the identity of recipient based on sensor data).
16. Regarding claims 18 and 72 Mishra teaches the apparatus and the method, wherein the response is determined as a function of the data access requestor’s location authenticated based on sensor data (Para:0110-0112 teaches location based authentication).
17. Regarding claim 20 Mishra teaches the apparatus, wherein the operations performed by the processor further comprise in response to a patient giving consent to a data access request, creating a provider encounter data bundle (Para:0060-0061 and Para:0067 teaches based on data request consent determine which attributes or fields of a given patient record is allowed to access).
18. Regarding claim 21 Mishra teaches the apparatus, wherein the provider encounter data bundle structure is designed to permit individual access to patient data fields and records (Para:0060-0061 and Para:0067 teaches permitting access to patient data fields).
19. Regarding claim 43 Mishra teaches an apparatus comprising: a processor; and a memory that is not a transitory propagating signal, the memory configured to be operably connected to the processor and including computer readable instructions, including processor executable program instructions, the computer readable instructions accessible to the processor, wherein the processor executable instructions, when executed by the processor, cause the processor to perform operations comprising: in response to receiving a request to download a patient’s stored health record data encrypted with storage encryption parameters: determine if the patient has given consent for the requestor to download the patient’s health record data (Para:0125-0126 and Para:0155-0156 teaches receiving a request to download a stored encrypted health data record. Based on identification and/or authentication of the identity of the user, the consent may be provided by record owners as part of a request);
and in response to determining the patient has given consent: configure secure access by the requestor to the patient’s health record data, based on providing the requestor access encryption parameters distinct from the storage encryption parameters (Para:0108-0109 and Para:0137-0138 teaches prior to transmission, the encrypted health data record may be first decrypted using the local cryptographic key of the sending device. The decrypted data may then be encrypted using a cryptographic key, known to both sender, and receiver and that is created dynamically to exist only during the lifetime of the communication session. The Diffie-Hellman algorithm may be used to create a communication session cryptographic key in such a way that only the two mobile devices 502 and 508 know the key. When encrypted data is received at the destination device 508 or 502, it can be decrypted using the key associated with current proximity exchange and then re-encrypted using the local cryptographic key of the destination device before it is stored);
and provide the secure access to the requestor for a specific device at a location and time related to the request (Para:0125-0126 and Para:0112 teaches records will not be exchanged without a positive identification of the recipient. When the record holder and the healthcare provider are located in different physical locations, a location identification made by one or more of the record holder and the healthcare provider using one or more of a global positioning system and location information provided by a wireless network. For example, certain wireless network telecommunications services can provide accurate positional information based on triangulation and/or certain signaling characteristics of mobile devices. An authentication or other service may be used to verify identity of, and subsequently connect a record holder and a healthcare provider when the parties are located different physical locations. Para:0147 teaches the record owner will also provide time-limited consent to permit a provider to request and access patient records);
and in response to determining the patient has not given consent: deny the request (Para:0111-0112 teaches the records will not be exchanged without a positive identification of the recipient i.e., denial to the data access request).
20. Regarding claim 44 Mishra teaches the apparatus, wherein the apparatus further comprises a cloud database operably coupled with the processor, and provide the secure access further comprises provide the secure access to the health record data by the database (Para:0104-0105 teaches provide access to the health record by the database).
21.Regarding claim 45 Mishra teaches the apparatus, wherein receiving the request to download the patient’s health record data further comprises receiving a digital message comprising the request (Para:0095 and Para:0108-0109 teaches receiving a digital message for data access request).
22. Regarding claim 46 Mishra teaches the apparatus, wherein determine if the patient has given consent further comprises determine if the patient’s consent is predetermined for the requestor (Para:0108 and Para:0111-0112 teaches consent is predetermined for the requestor).
23.Regarding claim 47 Mishra teaches the apparatus, wherein determine if the patient has given consent further comprises send a digital message comprising a request for the patient’s consent (Para:0095 and Para:0108 teaches a request for the patient’s consent) .
24. Regarding claim 48 Mishra teaches the apparatus, wherein determine if the patient has given consent further comprises receive a digital message comprising the patient’s consent (Para:0095 and Para:0108 -0109 teaches receiving patient’s consent) .
25. Regarding claim 49 Mishra teaches the apparatus, wherein the health record data further comprises a plurality of data fields (Para:0060 teaches the health record comprises plurality of data fields.
26. Regarding claim 50 Mishra teaches the apparatus, wherein the access parameters further comprise an encrypted reference to a unique session key configured to secure the health record data in transit (Para:0108-0109 and Para:0137-0138 teaches prior to transmission, the encrypted health data record may be first decrypted using the local cryptographic key of the sending device. The decrypted data may then be encrypted using a cryptographic key, known to both sender, and receiver and that is created dynamically to exist only during the lifetime of the communication session. The Diffie-Hellman algorithm may be used to create a communication session cryptographic key in such a way that only the two mobile devices 502 and 508 know the key. When encrypted data is received at the destination device 508 or 502, it can be decrypted using the key associated with current proximity exchange and then re-encrypted using the local cryptographic key of the destination device before it is stored).
27. Regarding claim 51 Mishra teaches the apparatus, wherein provide the secure access to the requestor for a specific device at a location and time related to the request further comprises the device authenticated based on a security certificate (Para:00111-0115 teaches secure access to the data based on device authentication).
28. Regarding claim 52 Mishra teaches the apparatus, wherein provide the secure access to the requestor for a specific device at a location and time related to the request further comprises the location determined based on sensor data (Para:0112 and Para:0147 teaches records may not be exchanged without a positive identification of the recipient. When the record holder and the healthcare provider are located in different physical locations, a location identification made by one or more of the record holder and the healthcare provider using one or more of a global positioning system and location information provided by a wireless network. For example, certain wireless network telecommunications services can provide accurate positional information based on triangulation and/or certain signaling characteristics of mobile devices. In some embodiments, an authentication or other service may be used to verify identity of, and subsequently connect a record holder and a healthcare provider when the parties are located different physical locations).
29. Regarding claim 53 Mishra teaches the apparatus, wherein provide the secure access to the requestor for a specific device at a location and time related to the request further comprises the access time limited based on the access parameters configured to expire at a predetermined time (Para:0125 and Para:0147 teaches the record owner will also provide time-limited consent to permit a provider to request and access patient records).
30. Regarding claim 54 Mishra teaches the apparatus, wherein deny the request further comprises send a digital message comprising request denial (Para:0111-0112 teaches the records will not be exchanged without a positive identification of the recipient i.e., denial to the data access request).
Claim Rejections - 35 USC § 103
31.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.
32.Claim(s) 5 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (US Pub.No.2016/0103963) in view of Paffel (US Pub.No.2015/0058627).
33. Regarding claims 5 and 59 Mishra teaches all the above claimed limitation but fails to teach the apparatus and the method, wherein the data access request further comprises a data delete operation request.
Paffel teaches the data access request further comprises a data delete operation request (Para:0212 teaches data delete operation request).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filing to modify Mishra to include the data access request further comprises a data delete operation request, as taught by Paffel such a setup would perform the delete request correctly can be necessary to comply with data protection regulation, such as the right to erasure, which requires organizations to delete personal data upon request.
34. Claim(s) 7-13 and 61-67 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (US Pub.No.2016/0103963) in view of Saad (US Pub.No.2022/0012360).
35. Regarding claims 7 and 61 Mishra teaches all the above claimed limitation but fails to teach the apparatus and the method, wherein store the patient’s health record data further comprises separate the health record data into a plurality of data fields based on the data type.
Saad teaches the stored patient’s health record data further comprises separate the health record data into a plurality of data fields based on the data type (Para:0013-0015, Para:0021 and claim 11 teaches storing the user data into a plurality of data fields based on the data type, wherein the user data comprises of patent health data).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filing to modify Mishra to include separate the health record data into a plurality of data fields based on the data type, as taught by Saad. Mishra already teaches the patient record or information comprises one or more attributes or fields (see, para:0060) and the combination with Saad would give a predictable result of storing the plurality of health data fields with appropriate data type, which will result in improved and faster data access/retrieval.
36. Regarding claims 8 and 62 Mishra in view of Saad teaches the apparatus and the method, wherein store the patient health record data further comprises encrypt each data field of the plurality of data fields with a storage encryption parameter comprising an encryption key uniquely determined as a function of information related to the patient (Saad: Para:0013-0015, Para:0021 and claim 11 teaches plurality of different encryption keys to the different data fields).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filing to modify Mishra to include encrypt each data field of the plurality of data fields with a storage encryption parameter comprising an encryption key uniquely determined as a function of information related to the patient, as taught by Saad such a setup would give a predictable result of secured and faster data access.
37. Regarding claims 9 and 63 Mishra in view of Saad teaches the apparatus and the method, wherein configure secure access further comprises configure distinct access encryption parameters for each data field of the plurality of data fields (Saad: Para:0013-0015, Para:0021 and claim 11 teaches different encryption keys to different data fields).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filing to modify Mishra to include distinct access encryption parameters for each data field of the plurality of data fields, as taught by Saad such a setup would give a predictable result of secured and faster data access.
38. Regarding claims 10 and 64 Mishra in view of Saad teaches the apparatus and the method, wherein the access encryption parameters further comprise a decryption key uniquely determined as a function of an individual data field (Saad: Para:0013-0015, Para:0021 and claim 11 teaches retrieves the appropriate decryption key for individual data fields).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filing to modify Mishra to include a decryption key uniquely determined as a function of an individual data field, as taught by Saad such a setup would give a predictable result of secured and faster data access.
39. Regarding claims 11 and 65 Mishra in view of Saad teaches the apparatus and the method, wherein the access encryption parameters further comprise a decryption key uniquely determined as a function of the data access request (Saad: Para:0013-0015, Para:0021 and claim 11 teaches retrieves the appropriate decryption key as a function of the data access).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filing to modify Mishra to include a decryption key uniquely determined as a function of the data access request, as taught by Saad such a setup would give a predictable result of secured and faster data access.
40. Regarding claims 12 and 66 Mishra in view of Saad teaches the apparatus and the method, wherein provide the secure access further comprises sending a digital message comprising the access encryption parameters (Mishra: Para:0095 the electronic health records (EHRs) will be in digital format. Para:000111-0112 and Para:0137-0138 teaches access encryption parameters for digital data transfer. Saad: Para:0013-0015, Para:0021 and claim 11) .
41. Regarding claims 13 and 67 Mishra in view of Saad teaches the apparatus and the method, wherein the digital message further comprises an encrypted reference to the decryption key (Mishra: Para:0095 the electronic health records (EHRs) will be in digital format. Para:000111-0112 and Para:0137-0138 teaches decrypting the data. Saad: Para:0013-0015, Para:0021 and claim 11).
42. Claims 19 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (US Pub.No.2016/0103963) in view of Rab (US Pub.No.2018/0276341).
43. Regarding claims 19 and 73 Mishra teaches all the above claimed limitation but fails to teach the apparatus and the method, wherein the operations performed by the processor further comprise in response to a patient withdrawing consent to data access, revoking the configured access to the data.
Rab teaches in response to a patient withdrawing consent to data access, revoking the configured access to the data (Para:0054 teaches the patient can revoke consent to patient's private health records).
Therefore, it would have been obvious to one of ordinary skill in the art before the invention was filing to modify Mishra to include in response to a patient withdrawing consent to data access, revoking the configured access to the data, as taught by Rab such a setup would allow individual to control their data, maintain privacy and confidentiality.
Conclusion
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/DEREENA T CATTUNGAL/Primary Examiner, Art Unit 2431