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 Claims
This action is in reply to Applicant’s communication filed on May 31, 2025.
Claims 1, 9, 15, 17 and 19 have been amended and are hereby entered.
Claims 1-5 and 7-22 are currently pending and have been examined.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 31, 2025 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 7-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 analysis:
Claims 1 and 15 are each directed to a method and therefore all fall into one of the four statutory categories. (Step 1: Yes, the claims fall into one of the four statutory categories).
Step 2A analysis - Prong one:
The substantially similar independent method claims, taking claim 1 as exemplary, recite the following limitations: receiving, by a processor, a request to transmit a medical report corresponding to a medical diagnosis to a third party, the medical report including outcome-based wellness scores determined for a plurality of patients diagnosed with the medical diagnosis using scored responses from each respective patient of the plurality of patients for one or more patient reported outcome questionnaires and improvement scores that indicate changes in the wellness scores for each respective patient of the plurality of patients over time; querying, by the processor, an electronic medical record database for the wellness scores and the improvement scores associated with the medical diagnosis; receiving, by the processor, a set of the wellness scores and the improvement scores associated with the medical diagnosis from the electronic medical record database; determining, by the processor, a medical diagnosis coding system used by the third party and a medical diagnosis code of the medical diagnosis coding system correlated to the medical diagnosis; determining, by the processor, a medical report formatting requirement of the third party; translating, by the processor, the set of the wellness scores and the improvement scores into a format compliant with the medical report formatting requirement of the third party using a determined medical report formatting requirement of the third party, wherein the medical report formatting requirement of the third party comprises: (i) translating the medical report into an accounting format compatible with the third party's accounting system (ii) encrypting the translated medical report with an encryption protocol selected from the group consisting of public or private key encryption, transport layer security (TLS), and secure socket layer (SSL) prior to providing the medical report to a requester, and (iii) storing the encrypted medical report on a blockchain, the storing being a required condition for the third party to evaluate and process the medical report; generating, by the processor, the medical report using the translated set of the wellness scores and the improvement scores; and providing, by the processor, the medical report to the requester.
The examiner is interpreting the above bolded limitations as additional elements as further discussed below.
Translating the set of the wellness scores and the improvement scores into a compliant format is included as a part of the abstract idea because a translation of scores may be interpreted as simply changing/converting units, adjusting the scale for the score, etc. which are abstract ideas. Further, the limitations regarding translating the medical report into an accounting format compatible with the third party is included as part of the abstract idea because this translation may be interpreted as simply converting units, adjusting scales, etc. which are abstract ideas. Examiner notes that the two translating steps are not currently reciting anything technical in nature that would lead to the conclusion that these limitations are additional elements; for example, converting file formats or data conversion that can only be performed by a computer and not by a human/by hand.
The non-bolded limitations above, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting a method implemented by a processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the use of a processor, a database, translating record formats for compatibility with an accounting system, encryption protocols and a blockchain, this claim encompasses a person analyzing and processing medical records by categorizing, re-formatting and encrypting the records prior to providing the records to a person requesting the medical records in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior 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 claim recites an abstract idea. (Step 2A – Prong 1: Yes, the claims are abstract).
Step 2A analysis - Prong two:
Claims 1 and 15 recite the following additional elements beyond the abstract idea: a processor, an electronic medical record database, an accounting system, transport layer security (TLS), and secure socket layer (SSL), and a blockchain.
This judicial exception is not integrated into a practical application. In particular, the claims recite a processor, an electronic medical record database, an accounting system, transport layer security (TLS), and secure socket layer (SSL), and a blockchain which are recited at a high-level of generality (i.e., as a generic processor performing generic computer functions) such that it amounts to no more than mere instructions to apply the exceptions using generic computer components. For example, Applicant’s specification explains that the electronic medical record database stores patient data, is coupled to computer systems, may be queried, etc. (see Applicant’s spec. pages 6, 8, 10, 13, 21) and the processor reads instructions, executes control functions, receives electrical inputs, analyzes data, outputs results, etc. (see Applicant’s spec. paras 49-51). Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, Claims 1 and 15 are directed to an abstract idea without practical application. (Step 2A – Prong 2: No, the additional claimed elements are not integrated into a practical application).
Step 2B analysis:
For the next step of the analysis, it must be determined whether the limitations present in the claims represent a patent-eligible application of the abstract idea. A claim directed to a judicial exception must be analyzed to determine whether the elements of the claim, considered both individually and as an ordered combination are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself.
Applicant’s specification discloses the following:
Applicant describes embodiments of the disclosure at a very high level to include the use of a wide variety of user devices, processors, computers, memories, databases and storage devices, input/output devices, encryption protocols, communication interfaces, software/programs, smart contracts, blockchain, etc. (See Applicant’s specification pages 6-7, 16-17, 23, 26-27).
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. Looking at the 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. The collective functions appear to be implemented using conventional computer systemization.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a processor, an electronic medical record database, an accounting system, transport layer security (TLS), secure socket layer (SSL), and a blockchain to perform all of the steps discussed above amount to no more than mere instructions to apply the exceptions using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). The claims do not provide an inventive concept significantly more than the abstract idea. Accordingly, these additional elements, when considered separately and as an ordered combination, 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: No, the claims do not provide significantly more).
Dependent Claims 2-5, 7-14 and 16-22 further define the abstract idea that is presented in independent Claims 1 and 15 respectively, and are further grouped as certain methods of organizing human activity and are abstract for the same reasons and basis as presented above. Further, Claims 7-8, 10, 17-18 and 20 recite additional elements beyond the abstract idea. Claims 7 and 17 recite digitally signing the medical report with a digital security certificate. Claims 8 and 18 recite digitally locking the medical report. Claims 10 and 20 recite a smart contract. These additional elements are recited at a high level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. For example, as noted above, the Applicant’s specification indicates the use of known encryption protocols for digitally signing and digitally locking (see Applicant’s Spec. Para 81). Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims do not recite additional elements that integrate the judicial exception into a practical application when considered both individually and as an ordered combination. Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 1-5 and 7-22 are rejected under 35 U.S.C. 101 as being directed to abstract ideas without significantly more.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 7-22 are rejected under 35 U.S.C. 103 as being unpatentable over Saliman et al. (US 20170372029) in view of Saliman et al. (US 20200005912) (hereinafter referred to as Saliman-2), in view of Yoon et al. (US 20190354693), further in view of Casey et al. (US 20030120632).
Regarding Claim 1, Saliman discloses the following limitations:
A computer-implemented method, comprising: receiving, by a processor, a request to transmit a medical report corresponding to a medical diagnosis to a third party, (Saliman discloses receiving a request to provide a plurality of wellness scores (receiving a request to communicate a medical report) for a plurality of patients who are each associated with a diagnosis (corresponding to a medical diagnosis). Outcome data includes responses to questionnaires from which the wellness and improvement scores are determined. Treatment providers, hospital centers and insurance providers (a third party) may access and use the outcome data for various purposes. – paras 30, 105-107)
the medical report including outcome-based wellness scores determined for a plurality of patients diagnosed with the medical diagnosis using scored responses from each respective patient of the plurality of patients for one or more patient reported outcome questionnaires (Saliman discloses that responses to a medical questionnaire provided to each of a plurality of patients (using scored responses from each respective patient of the plurality of patients for one or more patient reported outcome questionnaires) are received and a wellness score is determined (outcome-based wellness scores determined) with regard to a medical condition (for a plurality of patients diagnosed with the medical diagnosis). Further, an electronic medical record of the patient may be accessed and information about the patient from the accessed electronic medical record may be extracted and correlated, for example, the wellness score (the medical report including outcome-based wellness scores), the received set of responses, a diagnosis of the patient, a treatment provided to the patient, and/or the medical questionnaire. – paras 4-6, 12)
and improvement scores that indicate changes in the wellness scores for each respective patient of the plurality of patients over time; (Saliman discloses that the improvement scores may be determined using the wellness score and the subsequent wellness score and/or a difference in the wellness score and the subsequent wellness score (indicate changes in the wellness scores). the provision of the medical questionnaire to the patient at a plurality of time points (e.g., daily, weekly, monthly, quarterly, biannually, yearly, etc.) may be repeatedly facilitated so as to monitor the patient's wellness over time (e.g., weeks, months, years, decades) (changes in the wellness scores…over time). – paras 10, 14, 25, 30, 50)
querying, by the processor, an electronic medical record database for the wellness scores and the improvement scores associated with the medical diagnosis; (Saliman discloses that one or more databases that store a plurality of previously determined wellness scores (an electronic medical record database for wellness scores) and determined improvement scores (improvement scores) may be accessed and/or queried (querying). Wherein the scores are determined with regard to a medical condition (associated with the diagnosis). – paras 4, 16-18, 29-30, 408, 492; FIG. 14C)
receiving, by the processor, a set of the wellness scores and the improvement scores associated with the medical diagnosis from the electronic medical record database; (Saliman discloses that a score and/or a patient EMR database (the electronic medical record database) may be queried and/or accessed to extract (receiving) the requested wellness and/or improvement scores (a set of wellness scores and improvement scores) associated with a medical condition (associated with the diagnosis). – paras 4, 16-18, 29-30, 408, 492; FIG. 14C)
determining, by the processor, a medical diagnosis coding system used by the third party and a medical diagnosis code of the medical diagnosis coding system correlated to the medical diagnosis; (Saliman discloses that after receiving responses from the patients, the responses are associated with treatment and/or diagnostic codes (a medical diagnosis code of the medical treatment coding system). A hospital procedure ICD-9 code and CPT codes (a medical diagnosis coding system) may be used for example and the medical literature database operated by a third party (a medical diagnosis coding system used by the third party) may be accessed to determine the treatment and/or diagnostic code(s) to be used. – paras 148, 186, 172; FIG. 3)
determining, by the processor, a medical report formatting requirement of the third party; (Saliman discloses that the wellness and/or improvement score(s) may be transformed into numbers and/or statements so that the scores are more meaningful to, and/or more easily understood (formatting requirement) by the patient or a third party (e.g., treatment providers, hospital centers, and insurance providers) who may also use the patient reported outcome data.– paras 16, 107, 152-153, 328-329)
translating, by the processor, the set of the wellness scores and the improvement scores into a format compliant with the medical report formatting requirement of the third party using a determined medical report formatting requirement of the third party, (Saliman discloses that the raw wellness score may be adjusted (translating) to be on a normalized (e.g., base ten) scale, thereby generating an adjusted wellness score. – paras 16, 182, 299-300)
(ii) encrypting the translated medical report with an encryption protocol… , prior to providing the medical report to a requester; (Saliman discloses that the treatment facility computer system and its associated patient electronic medical record (EMR) database may be protected by HIPAA-compliant firewall (encrypting the translated medical report with an encryption protocol) or the patient-identifying information is encrypted prior to passing between two or more system components (prior to providing the medical report to a requester) where privacy vulnerabilities may exist. – paras 111, 143; FIG 1A item 140)
generating, by the processor, the medical report using the translated set of the wellness scores and the improvement scores; (Saliman discloses that a plurality of previously determined wellness scores (a medical report) for a plurality of patients may be generated. The raw wellness score (e.g., a wellness score, an improvement score, a treatment effectiveness score, a treatment provider effectiveness score, a treatment facility effectiveness score, etc.) may be adjusted to be on a normalized scale, thereby generating an adjusted wellness score (using a translated set of the wellness scores and improvement scores). – abstract; paras 16, 119-120)
and providing, by the processor, the medical report to the requester. (Saliman discloses providing the modified treatment outcome wellness scores to the requester. – paras 394, 420; FIG 14A item 1435)
Saliman does not disclose the following limitations met by Saliman-2:
…an encryption protocol selected from the group consisting of public or private key encryption, transport layer security (TLS), and secure socket layer (SSL)…; (Saliman-2 teaches securely storing patient information and providing access thereto. Maintaining privacy while using this open availability (prior to providing the medical report to a requester) may be facilitated via one or more security protocols (encrypting the translated medical report with an encryption protocol) (e.g., public/private key encryption (public or private key encryption), passwords, etc.). – paras 4, 36)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified providing patient wellness and improvement scores to requesters as disclosed by Saliman to incorporate securely encrypting and storing patient information as taught by Saliman-2 in order to adequately protect sensitive information from security threats (see Saliman-2 para 3).
Saliman and Saliman-2 do not disclose the following limitations met by Yoon:
and (iii) storing the encrypted medical report on a blockchain, the storing being a required condition for the third party to evaluate and process the medical report; (Yoon teaches that the blockchain network 100 includes a consumer device 130 capable of requesting medical data of the user stored on the blockchain (the storing being a required condition for the third party to evaluate and process the medical report). A data block is generated and stored, therein the created metadata of the medical data and the encrypted medical data, and the generated data block is stored within a distributed ledger such that the generated data block is hash-linked to a previous data block on the distributed ledger (storing the encrypted medical report on a blockchain). – Abstract; paras 4-5, 28)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified providing patient wellness and improvement scores to requesters as disclosed by Saliman to incorporate storing patient data on a blockchain as taught by Yoon in order to facilitate the exchange of health-related information while alleviating the burden on organizations involved in the exchange (see Yoon para 3).
Saliman, Saliman-2 and Yoon do not disclose the following limitations met by Casey:
wherein the medical report formatting requirement of the third party comprises: (i) translating the medical report into an accounting format compatible with the third party's accounting system (Casey teaches that information is retrieved from a database/storage location and reformatted (translating the medical report to meet individual medical provider requirements compatible with the medical provider's internal billing systems (into an accounting format compatible with the third party's accounting system). – abstract; paras 4, 12)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified providing patient wellness and improvement scores to requesters as disclosed by Saliman to incorporate converting data into a compatible format for the receiving computer system as taught by Casey in order to avoid having to manually request and input the information (see Casey para 4).
Regarding Claim 2, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, wherein the formatting requirement of the third party is a format for use when auditing a treatment provider providing a treatment for the diagnosis. (Saliman-2 teaches that exemplary requesters include auditors who assess performance metrics for various providers of medical and healthcare services (auditing a treatment provider providing a treatment). – paras 82-89)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified providing wellness and improvement scores to requesters as disclosed by Saliman to incorporate storing personal medical data in a blockchain and broadcasting to the blockchain as taught by Saliman-2 in order to adequately protect sensitive information from security threats (see Saliman-2 para 3).
Regarding Claim 3, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, wherein the formatting requirement of the third party is a format for use when determining a treatment outcome-based performance for a treatment provider providing a treatment for the diagnosis. (Saliman discloses that the outcome data can also be used by, for example, treatment providers, hospital centers, and insurance providers (the third party) for quality assurance and quality improvement purposes (a format for use when determining a treatment outcome-based performance for a treatment provider). Use of the outcome data may enable hospitals and other treatment facilities to better discern which clinicians fall short of delivering a satisfactory level of care, and better defend their decisions to terminate clinicians who under-perform. – paras 16-17, 16, 107, 152-153, 328-329)
Regarding Claim 4, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, wherein the formatting requirement of the third party is a scale for the determination of the wellness scores (Saliman discloses that, in some instances, the wellness score is a raw wellness score provided on a scale determined by the scoring procedure (a scale for the determination of wellness scores) that is, for example, not a base ten scale (i.e., not 0-10 or 0-100). – paras 16, 299-300, 328-329)
and wherein translating the set of the wellness scores into a format compliant with the medical report formatting requirement of the third party includes normalizing the scale of the wellness scores to the third party's scale for the determination of the wellness scores. (Saliman discloses that in some instances, adjusting the wellness score may include normalizing the wellness score to be on a scale common to all of the wellness scores provided (normalizing the scale of the wellness scores (i.e., a normalized scale). – paras 107, 299-300, 328-329)
Regarding Claim 5, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, wherein the formatting requirement of the third party is a scale for the determination of the improvement scores (Saliman discloses converting a score (improvement scores) calculated on a scale that is not readily understood, to a scale that is more easily understood (a scale for the determination of improvement scores) by most people. – paras 10, 16, 299-300, 328-329)
and wherein translating the set of the improvement scores into a format compliant with the medical report formatting requirement of the third party includes normalizing the scale of the improvement scores to the third party's scale for the determination of the improvement scores. (Saliman discloses adjusting the wellness and/or improvement score(s) so that they are provided on a common scale. This may be done by normalizing wellness and/or improvement score(s) to a normalized scale (e.g., base ten) before facilitating provision of the adjusted wellness score to the requester. – paras 10, 16, 299-300, 302, 328-329)
Regarding Claim 7, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, wherein the formatting requirement of the third party is that the medical report be digitally signed with a digital security certificate, the method further comprising: digitally signing, by the processor, the medical report with a digital security certificate, prior to providing the medical report to the requester. (Saliman-2 teaches that, in some instances, the set of responses may be digitally signed (digitally signing the medical report). This may occur prior to packaging the set of responses (prior to providing the medical report to the requester) and if so, the digitally signed and packaged set of responses may be broadcast to the blockchain. – paras 9, 35, 41, 61)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified providing wellness and improvement scores to requesters as disclosed by Saliman to incorporate digital signatures as taught by Saliman-2 in order to adequately protect sensitive information from security threats (see Saliman-2 para 3).
Regarding Claim 8, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, wherein the formatting requirement of the third party is that the medical report be digitally locked to prevent modification prior to communication to the third party, the method further comprising: digitally locking, by the processor, the medical report prior to providing the medical report to the requester. (Saliman-2 teaches electronic medical record information provided by a medical note interface (providing the medical report to the requester) may be subject to one or more filters or permissions such as locking the medical note interface (digitally locking the medical report) prevent any further modification of the information included thereon and/or associated therewith. – paras 75-80)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified providing wellness and improvement scores to requesters as disclosed by Saliman to incorporate locking of electronic medical record information as taught by Saliman-2 in order to adequately protect sensitive information from security threats (see Saliman-2 para 3).
Regarding Claim 9, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, comprising: packaging, by the processor, the medical report to be stored on the blockchain prior to providing the medical report to the requester; (Saliman-2 teaches that a set of responses to a medical questionnaire may be received from a patient and packaged for storage on a blockchain. A requester may request access to a patient account stored in a blockchain (stored on the blockchain prior to providing the medical report to the requester). – abstract; paras 5-10, 68; FIG 8)
and broadcasting, by the processor, a packaged medical report to the blockchain. (Saliman-2 teaches that the packaged set of responses can then be broadcast, or otherwise communicated, to the blockchain. – abstract; paras 5-10, 72; FIG. 8)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified providing wellness and improvement scores to requesters as disclosed by Saliman to incorporate storing personal medical data in a blockchain and broadcasting to the blockchain as taught by Saliman-2 in order to adequately protect sensitive information from security threats (see Saliman-2 para 3).
Regarding Claim 10, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 9, wherein provision of the packaged medical report to the third party fulfils a requirement of a smart contract. (Saliman-2 teaches that smart contracts may relate to communication between, for example, the patient and his or her treatment provider, treatment facility, and/or health insurance company. A smart contract includes smart contract a requirement and a condition. When the requirement (provision of the packaged medical report) is met (viewership rights, answering questions, performing tasks, completing the medical questionnaire and/or OMD, and/or completing a percentage of the total questions provided by the medical questionnaire, etc.) then the condition may be fulfilled (monetary rewards, awards of points, access to privileges, etc.) (fulfils a requirement of a smart contract). – paras 10, 44-49)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified providing wellness and improvement scores to requesters as disclosed by Saliman to incorporate the use of smart contracts as taught by Saliman-2 in order to adequately protect sensitive information from security threats (see Saliman-2 para 3).
Regarding Claim 11, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, further comprising: providing, by the processor, the medical report directly to the third party. (Saliman discloses that a treatment facility computer system and/or a third-party computer system are directly or indirectly communicatively coupled to the server. – paras 110-111, 142, 145; FIG. 1A; FIG 1C)
Regarding Claim 12, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, further comprising: receiving, by the processor, a request to filter patients receiving a treatment for the medical diagnosis who are diagnosed with a comorbidity; (Saliman discloses that the request (receiving a request) may include one or more filters and/or selection criteria (filter patients) by which to select the information provided in response to the request. For example, the user may request to see wellness scores associated with a diagnosis, combination of diagnoses, treatment, combination of treatments, or patients with consistent comorbidities (filter patients receiving a treatment for the diagnosis who are diagnosed with a comorbidity). – paras 52, 132-133, 383, 392-393, 407, 420, 532, 550, 555)
and filtering, by the processor, the set of the wellness scores and the improvement scores associated with the medical diagnosis to remove patients receiving the treatment for the medical diagnosis who are diagnosed with the comorbidity prior to generating the medical report. (Saliman discloses that the request may include a request to view wellness and/or improvement scores for patients (patients receiving the treatment for the diagnosis) with consistent comorbidities (remove patients who are diagnosed with the comorbidity). FIG 32B also shows adding and removing of patient scores based on selected criteria (filtering the set of wellness scores and improvement scores). – paras 52, 132-133, 392-393, 407, 420, 512; FIG. 32B)
Regarding Claim 13, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, further comprising: receiving, by the processor, a request to filter patients receiving a treatment for the medical diagnosis who are diagnosed with a confounding injury; (Saliman discloses that the request (receiving a request) may include one or more filters and/or selection criteria (filter patients) by which to select the information provided in response to the request. For example, the user may request to see wellness scores associated with a diagnosis, combination of diagnoses, treatment, combination of treatments, or a combination of diagnosis/diagnoses and treatment(s) (receiving a treatment for the diagnosis). – paras 52, 132-133, 383, 392-393, 407, 532, 550, 555)
and filtering, by the processor, the set of the wellness scores and the improvement scores associated with the medical diagnosis to remove patients receiving the treatment for the medical diagnosis who are diagnosed with the confounding injury prior to generating the medical report. (Saliman discloses that the request may include a request to view wellness and/or improvement scores for patients with consistent comorbidities (remove patients who are diagnosed with the confounding injury). FIG 32B also shows adding and removing of patient scores based on selected criteria. – paras 52, 132-133, 392-393, 407, 420, 512; FIG. 32B)
Regarding Claim 14, Saliman, Saliman-2, Yoon and Casey disclose all the limitations above and further disclose the following limitations:
The computer-implemented method of claim 1, wherein the plurality of patients are treated for the diagnosis by a treatment facility. (Saliman discloses treatment effectiveness scores being aggregated for a group of patients (the plurality of patients) treated by the treatment provider. A treatment is typically performed by a treatment provider, in a healthcare administration facility, also referred to herein as a treatment facility (treated for the diagnosis by a treatment facility). – paras 108, 111, 136-137)
Regarding Claim 15, Saliman discloses the following limitations:
A computer-implemented method, comprising: receiving, by a processor, a request to communicate a medical diagnosis and medical report corresponding to a treatment provider to a third party, (Saliman discloses receiving a request to provide a plurality of wellness scores for a plurality of patients who are each associated with a treatment and a diagnosis (receiving a request to communicate a medical diagnosis and treatment report) and a particular treatment provider or group of treatment providers (corresponding to a treatment provider). Outcome data includes responses to questionnaires from which the wellness and improvement scores are determined. Treatment providers, hospital centers and insurance providers (a third party) may access and use the outcome data for various purposes. – abstract; paras 30, 105-107)
the medical report including outcome-based wellness scores determined for a plurality of patients treated by the treatment provider using scored responses from each respective patient of the plurality of patients for one or more patient reported outcome questionnaires (Saliman discloses that responses to a medical questionnaire provided to each of a plurality of patients (using scored responses from each respective patient of the plurality of patients for one or more patient reported outcome questionnaires) are received and a wellness score is determined (outcome-based wellness scores determined) with regard to a medical condition (for a plurality of patients diagnosed with the medical diagnosis). Further, an electronic medical record of the patient may be accessed and information about the patient from the accessed electronic medical record may be extracted and correlated, for example, the wellness score (the medical report including outcome-based wellness scores), the received set of responses, a diagnosis of the patient, a treatment provided to the patient, and/or the medical questionnaire. – paras 4-6, 12)
and improvement scores that indicate changes in the wellness scores for each respective patient of the plurality of patients over time; (Saliman discloses that the improvement scores may be determined using the wellness score and the subsequent wellness score and/or a difference in the wellness score and the subsequent wellness score (indicate changes in the wellness scores). the provision of the medical questionnaire to the patient at a plurality of time points (e.g., daily, weekly, monthly, quarterly, biannually, yearly, etc.) may be repeatedly facilitated so as to monitor the patient's wellness over time (e.g., weeks, months, years, decades) (changes in the wellness scores for each respective patient of the plurality of patients over time). – paras 10, 14, 25, 30, 50)
querying, by the processor, an electronic medical record database for the wellness scores and the improvement scores associated with the treatment provider; (Saliman discloses that one or more databases, such as a treatment-provider-specific registry of information, that store a plurality of previously determined wellness scores (an electronic medical record database for wellness scores) and determined improvement scores (improvement scores) associated with a treatment provider (associated with the treatment provider) may be accessed and/or queried (querying). – paras 4, 16-18, 29-30, 408, 414, 492; FIG. 14C, item 1484)
receiving, by the processor, a set of the wellness scores and the improvement scores associated with the treatment provider from the electronic medical record database; (Saliman discloses that a score database (the electronic medical record database) such as a treatment-provider-specific registry of information (associated with the treatment provider) may be queried and/or accessed to extract (receiving) the requested wellness and/or improvement scores (a set of wellness scores and improvement scores). – paras 4, 16-18, 29-30, 408, 414, 492; FIG. 14C, item 1486)
determining, by the processor, a medical report formatting requirement of the third party; (Saliman discloses that the wellness and/or improvement score(s) may be transformed into numbers and/or statements so that the scores are more meaningful to, and/or more easily understood (formatting requirement) by the patient or a third party (e.g., treatment providers, hospital centers, and insurance providers) who may also use the patient reported outcome data.– paras 16, 107, 152-153, 328-329)
translating, by the processor, the set of the wellness scores and the improvement scores into a format compliant with the medical report formatting requirement of the third party using a determined medical report formatting requirement of the third party, (Saliman discloses that the raw wellness score may be adjusted (translating) to be on a normalized (e.g., base ten) scale, thereby generating an adjusted wellness score. – paras 16, 182, 299-300)
(ii) encrypting the translated medical report with an encryption…prior to providing the medical report to a requester, (Saliman discloses that the treatment facility computer system and its associated patient electronic medical record (EMR) database may be protected by HIPAA-compliant firewall (encrypting the translated medical report with an encryption protocol) or the patient-identifying information is encrypted prior to passing between two or more system components (prior to providing the medical report to a requester) where privacy vulnerabilities may exist. – paras 111, 143; FIG 1A item 140)
generating, by the processor, a medical report using the translated set of the wellness scores and the improvement scores; (Saliman discloses that a plurality of previously determined wellness scores (a medical report) for a plurality of patients may be generated. The raw wellness score (e.g., a wellness score, an improvement score, a treatment effectiveness score, a treatment provider effectiveness score, a treatment facility effectiveness score, etc.) may be adjusted to be on a normalized scale, thereby generating an adjusted wellness score (using a translated set of the wellness scores and improvement scores). – abstract; paras 16, 119-120)
and providing, by the processor, the medical report to the requester. (Saliman discloses providing the modified treatment outcome wellness scores to the requester. – paras 394, 420; FIG 14A item 1435)
Saliman does not disclose the following limitations met by Saliman-2:
…an encryption protocol selected from the group consisting of public or private key encryption, transport laver security (TLS), and secure socket laver (SSL)… (Saliman-2 teaches securely storing patient information and providing access thereto. Maintaining privacy while using this open availability (prior to providing the medical report to a requester) may be facilitated via one or more security protocols (encrypting the translated medical report with an encryption protocol) (e.g., public/private key encryption (public or private key encryption), passwords, etc.). – paras 4, 36)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified providing patient wellness and improvement scores to requesters as disclosed by Saliman to incorporate securely encrypting and storing patient information as taught by Saliman-2 in order to adequately protect sensitive information from security threats (see Saliman-2 para 3).
Saliman and Saliman-2 do not disclose the following limitations met by Yoon:
and (iii) storing the encrypted medical report on a blockchain, the storing being a required condition for the third party to evaluate and process the medical report; (Yoon teaches that the blockchain network 100 includes a consumer device 130 capable of requesting medical data of the user stored on the blockchain (the storing being a required condition for the third party to evaluate and process the medical report). A data block is generated and stored, therein the created metadata of the medical data and the encrypted medical data, and the generated data block is stored within a distributed ledger such that the generated data block is hash-linked to a previous data block on the distributed ledger (storing the encrypted medical report on a blockchain). – Abstract; paras 4-5, 28)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified providing patient wellness and improvement scores to requesters as disclosed by Saliman to incorporate storing patient data on a blockchain as taught by Yoon in order to facilitate the exchange of health-related information while alleviating the burden on organizations involved in the exchange (see Yoon para 3).
Saliman, Saliman-2 and Yoon do not disclose the following limitations met by Casey:
wherein the medical report formatting requirement of the third party comprises (i) translating the medical report into an accounting format compatible with the third party's accounting system, (Casey teaches that information is retrieved from a database/storage location and reformatted (translating the medical report) to meet individual medical provider requirements compatible with the medical provider's internal billing systems (into an accounting format compatible with the third party's accounting system). – abstract; paras 4, 12)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified providing patient wellness and improvement scores to requesters as disclosed by Saliman to incorporate converting data into a compatible format for the receiving computer system as taught by Casey in order to avoid having to manually request and input the information (see Casey para 4).
Regarding Claim 16, this claim depends on claim 15, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 2 above; thus, the same rejection applies.
Regarding Claim 17, this claim depends on claim 15, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 7 above; thus, the same rejection applies.
Regarding Claim 18, this claim depends on claim 15, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 8 above; thus, the same rejection applies.
Regarding Claim 19, this claim depends on claim 15, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 9 above; thus, the same rejection applies.
Regarding Claim 20, this claim depends on claim 19, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 10 above; thus, the same rejection applies.
Regarding Claim 21, this claim depends on claim 15, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 12 above; thus, the same rejection applies.
Regarding Claim 22, this claim depends on claim 15, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 13 above; thus, the same rejection applies.
Relevant Prior Art of Record Not Currently Being Applied
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure.
Westin et al. (US 20180336964) discloses identifying standardized format specifications based on the determined output destination type from retrieved metadata and converting medical data into a format compatible with the identified standardized format before delivering the converted medical data to the recipient.
Response to Arguments
Regarding rejections under 35 USC § 101 to Claims 1-5 and 7-22, Applicant’s arguments have been fully considered, and are not persuasive. The rejection has been updated in light of latest amendments. Applicant argues:
(a) Applicant respectfully submits that amended independent claim 1 is not directed to organizing human activity, but instead to a specific, concrete, and technical method for generating and formatting medical reports in compliance with third-party requirements, including encryption and blockchain storage. This process involves a series of technical steps that are implemented via a computing system and cannot be reasonably performed by humans. The claimed method is grounded in improving computer functionality and data security in the context of medical information technology. Contrary to the Office Action's allegation, the claimed steps are not directed to organizing human activity. Translating medical data into an accounting format compatible with third-party systems, applying encryption protocols (e.g., public/private key, TLS, SSL), and formatting for blockchain storage all require specialized computer processing, cryptographic handling, and protocol compliance. (p. 10-11).
Regarding (a), Examiner respectfully disagrees. MPEP 2106.04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to share medical records with a third party. Examiner notes that the limitations regarding the translation of data to be compliant with third party system, the use of certain encryption protocols, and the use of blockchain storage are identified as additional elements and not as part of the abstract idea. Whether or not these additional elements recite an improvement, and thus integrate the recited abstract idea into a practical application, is evaluated in step 2A Prong 2. See updated rejection above.
(b) Amended independent claim 15 recites similar features and for at least the reasons discussed above, also satisfies Prong Two of Step 2A. Therefore, Applicant respectfully submits that amended independent claims 1 and 15, and all claims dependent therefrom, are not directed to an abstract idea under Prong One of Step 2A. (p.13).
Regarding (b), Examiner respectfully disagrees. Based on response to arguments above, claim 1 is unpatentable and therefore similar independent claim 15 as well as all claims depending therefrom, are unpatentable according to the same rationale.
(c) When properly considered as a whole, amended independent claim 1 integrates the alleged judicial exception into a practical application and provides a technical solution in the field of medical information technology. Specifically, the claimed method addresses a technological problem pertaining to generating, securing, and formatting medical reports in compliance with third-party system requirements (e.g., insurance company, medical review board, auditors, or government entities). Applicant respectfully submits that, there exist multiple technical problems in the art associated with the generation of medical information reports, as current medical and healthcare systems:
> fail to provide detailed medical reports of treatments to objectively and scientifically track treatment outcomes for patients undergoing treatment.
> fail to provide treatment outcome information of treatments provided to patients for performance, regulatory, and financial auditing.
> fail to adapt medical reports to the specific formatting requirements of third-party entities. See at least paragraphs [0003], [00070], and [00071] of the as-filed Specification. (p. 14-15).
Regarding (c), Examiner respectfully disagrees. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicate that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. V. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the technological problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, the Applicant’s argued problem of providing detailed medical reports and treatment outcome information are interpreted as not being rooted in technology. The problems are not caused by nor related to computer technology and the claims do not provide any limitations that may be interpreted as technical improvements to computer technology. At best, Applicant’s identified problem is a record/data management problem.
MPEP 2106.05(f) - When determining whether a claim simply recites a judicial exception with the words “apply it” (or an equivalent), such as mere instructions to implement an abstract idea on a computer, examiners may consider the following: (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”. See Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); Intellectual Ventures I v. Symantec, 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015). While Applicant's third argued problem is a technical problem, there is no nexus between the argued problem and the argued solution because there is no indication that the claimed invention actually solves this problem. The Applicant has identified that there is a technical problem relating to adapting medical reports to the specific formatting requirements of third-party entities; however, there is no indication that the claim actually solves this problem. The claim does not define what types of data conversion may or may not be taking place, what data structures are involved or how they’re being manipulated, etc. and thus the claim may actually result in improper data conversion; we do not know. Because the claim does not explicitly solve the described technical problem, a practical application is not present.
(d) Use of a Particular Machine Integral to the Claim: The claimed method does not merely recite generic computer components, as alleged. Rather, amended independent claim 1 is implemented through a computing environment including a processor, electronic medical record database, encryption protocol, and blockchain infrastructure, each of which performs specific technical operations that are integral to the claim. The system automatically receives wellness and improvement scores, determines formatting requirements, translates and encrypts the reports, and stores the result on a blockchain for verifiable delivery to a third party. Accordingly, Applicant respectfully submits that amended independent claims 1 and 15 and all dependent claims are integrated into a practical application under Prong Two of Step 2A and are, therefore, directed to patent-eligible subject matter under 35 U.S.C. § 101. (p. 16-17).
Regarding (d), Examiner respectfully disagrees. MPEP 2106.04(d)(2) indicates that a practical application may be present where the judicial exception is implemented using or in conjunction with a particular machine or manufacture. The instant claims do not recite a particular machine and, instead, recite that the abstract idea is implemented by a general-purpose computer (e.g., see Applicants spec paras 49-51). MPEP 2106.05(b)(I) indicates that applying the judicial exception “by use of conventional computer functions does not qualify as a particular machine.” Because there is no particularity with respect to the computer that implements the abstract idea, thus requiring the Examiner to conclude that the abstract idea is implemented by a general-purpose computer, a practical application is not present.
Further, Based on response to arguments above, claim 1 is unpatentable and therefore similar independent claim 15 as well as all claims depending therefrom, are unpatentable according to the same rationale.
(e) In addition, Applicant submits that amended independent claim 1 is integrated into a practical application according to Prong Two of Step 2A of the patent eligibility analysis in a manner similar to Examples 41 for "Cryptographic Communications" and Example 42 for "Method for Transmission of Notifications When Medical Records Are Updated" cited in the subject matter eligibility examples. (p. 17).
Regarding (e), Examiner respectfully disagrees. MPEP 2106.04(d) sates that one way in which a claimed abstract idea may be subject matter eligible under prong 2A2 is if the claimed invention solves a described technological problem. Example 42 is an illustration of this. The Specification of Example 42 describes a technical problem (i.e., a problem caused by the technology): the technological implementation of software formats made it difficult to share updated health information. The claimed invention then solved this problem (a technical solution) by providing a message and access to updated real-time data that has been converted to a standardized format, thus integrating the abstract idea into a practical application. Unlike Example 42 and/or the technical solution to a technical problem inquiry, Applicant has not identified nor can the Examiner locate any technical problem that the claimed invention is solving, as noted in response to argument (c) above.
(f) Applicant respectfully submits that amended independent claim 1 amounts to "significantly more" than an abstract idea. Applicant respectfully submits that amended independent claim 1 recites an "inventive concept" through a non-conventional and specific arrangement of technical features addressing a real-world problem in the field of healthcare informatics. Applicant further submits that even if each individual element, such as retrieving EMR data, encrypting a file, or storing data on a blockchain, may be known, the ordered combination of these elements to solve a specific medical data compliance problem is not conventional. This integration results in a technical improvement in the field of medical information technology. Therefore, Applicant respectfully submits that amended independent claim 1 amounts to "significantly more" than an abstract idea under Step 2B. Amended independent claim 15 recites similar features and for at least the reasons discussed above, also satisfies Step 2B. Claims 2-5, 7-14, and 16-22 are dependent on, and incorporate the features of amended independent claims 1 and 15 and therefore are allowable by virtue of their dependency. Accordingly, Applicant respectfully requests that the rejection of claims 1-5 and 7-22 under 35 U.S.C. § 101 be withdrawn. (p. 17-20).
Regarding (f), Examiner respectfully disagrees. MPEP 2106.04(d)(1) states "the word 'improvements' in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B." Here there is no improvement to the computer nor is there an improvement to another technology. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application. Applicant's argument that the field of medical information technology is a technology and that the claimed invention improves this field is not reflected in the claimed invention. The claimed invention is merely using a computer as a tool and any improvement present is an improvement to the abstract idea of, to paraphrase, securely sharing medical data.
Further, Based on response to arguments above, claim 1 is unpatentable and therefore similar independent claim 15 as well as all claims depending therefrom, are unpatentable according to the same rationale.
Regarding rejections under 35 USC § 102 to Claims 1, 3-5, 11-15 and 21-22, Applicant’s arguments have been fully considered and are persuasive regarding the newly added limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection necessitated by Applicant’s amendments is made in view of Saliman et al. (US 20200005912) (hereinafter referred to as Saliman-2), in view of Yoon et al. (US 20190354693), further in view of Casey et al. (US 20030120632), as per the rejection above.
Applicant further argues that Saliman-2 fails to teach or suggest the features of amended claim 1. However, the Examiner relies upon Saliman-2 to teach the use of public and private key encryption protocols. See updated rejection above.
Conclusion
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/K.E.V./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681