DETAILED ACTION
This action is made in response to the communication filed on August 5, 2026. This action is made final.
Claims 1-20 are pending. Claims 1-5, 7-13, and 15-20 have been amended. Claims 1, 9, and 17 are independent claims.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The previous 101 rejection has been withdrawn in light of the new amendments.
Applicant’s argument with respect to the prior art rejection has been fully considered but is not persuasive. Applicant argues MacCarthy fails to teach “comparing a hash associated with the anonymized data to one or more stored hashes in a permanent storage at the second region to identify previously received health data associated with the same patient”. However, the examiner, respectfully, disagrees.
MacCarthy teaches the received hash tokens associated with the de-identified healthcare record can be compared against previously received hashed tokens in order to link healthcare records that correspond to the same patient (e.g., see [0047]). Accordingly, MacCarthy teaches the claimed limitation. Notably, newly cited Mawdsley is incorporated for teaching the newly added limitations of the “anonymized data having been decoupled from patient privacy information retained exclusively within the first region”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to dependent claims 8 and 16, the claims recite “wherein the analyzing further comprises: determining a format of the anonymized data; selecting a predetermined analysis type from a plurality of available analysis types for use in analyzing the anonymized data based on the determined format of the anonymized data; and generating a model based on the determined analysis type”. [0099] of the originally filed specification is the closest paragraph that resembles support. However, while the specification discloses detecting certain types of data files and generating a model based on the file and performing an analysis using the generated, the specification fails to teach determining a format of the data, selecting a predetermined analysis based on the determined format; and generating a model based on the determined analysis type. Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 16 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.
As to dependent claims 8 and 16, the claims recite “wherein the analyzing further comprises: determining a format of the anonymized data; selecting a predetermined analysis type from a plurality of available analysis types for use in analyzing the anonymized data based on the determined format of the anonymized data; and generating a model based on the determined analysis type”. However, wherein a format, such as a PDF can have both structure and unstructured data, it is unclear as to how the analyzing is performed based on a determined format. For the purposes of compact prosecution, the claim will be interpreted in a manner as best understood by the examiner and consistent with applicant’s originally filed specification [0099]. Accordingly, where the prior art teaches generating a model based on the type of data to perform an analysis, then it meets the claimed limitation.
Appropriate correction is required.
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.
Claims 1-3, 8-11, 13, 16, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over MacCarthy et al (USPPN: 2016/0147945; hereinafter MacCarthy) in further view of Mawdsley et al. (USPPN: 2012/0131075; hereinafter Mawdsley).
As to claim 1, MacCarthy teaches A computer-implemented method of analyzing anonymized data across regions (e.g., see Title, Abstract), the method comprising:
receiving, via a data storage device physically located within a second region, anonymized data from a first region (e.g., see Figs. 1, 4, [0019], [0023], [0025], [0040] wherein encrypted and de-identified (i.e., anonymized) data is received from one or more sources in different countries or regions);
determining an identifier associated with the anonymized data (e.g., see Figs. 1, 4, [0021], [0022] wherein the anonymized/de-identified data has anonymous linking tokens or indexing tags with which to identify healthcare data associated with the same individual);
comparing, via the data storage device, a hash associated with the anonymized data to one or more stored hashes in a permanent storage at the second region to identify previously received health data associated with a same patient (e.g., see [0047], [0067] wherein the hash tokens may be used to link de-identified healthcare data records by comparing the hashed tokens received with the encrypted and de-identified healthcare record with other hash tokens previously received that correspond to the same patient);
retrieving, from the permanent storage, stored health data associated with the same patient based on the comparison of the hash to the one or more stored hashes (e.g., see [0040], [0044], [0045], [0046], [0075] wherein encrypted and de-identified patient data associated with the anonymized patient identifier is retrieved, see also [0022] wherein the de-identified data have anonymous linking token or tags);
analyzing, via an analysis platform, the anonymized data based on the stored health data associated with the determined identifier (e.g., see [0040], [0046] wherein the encrypted and de-identified patient data associated with the anonymized patient identifier can be analyzed, wherein the system can be implemented on any hardware, software, server (i.e., platform));
generating, via the analysis platform physically located within the second region, a report of the analyzed anonymized data (e.g., see [0046], [0079] wherein the encrypted and de-identified patient data is analyzed to generate a cumulative report); and
transmitting, via the analysis platform, the report to a downstream entity located in the first region, the report being anonymous when transmitted to the first region (e.g., see Fig. 4, [0046], [0080] wherein the de-identified and encrypted report is sent to a requesting entity).
While McCarthy teaches anonymizing the data such that it is decoupled from patient privacy information in accordance with various jurisdictions and further teaches an identifier associated with the anonymized data, McCarthy fails to explicitly teach the anonymized data having been decoupled from patient privacy information retained exclusively within the first region; and the identifier being unrelated to the patient privacy information.
However, in the same field of endeavor of private information storage and retrieval, Mawdsley teaches the anonymized data having been decoupled from patient privacy information retained exclusively within the first region; and the identifier being unrelated to the patient privacy information (e.g., see Abstract, [0009], [0043], [0049], [0050], [0080], [0082] wherein data is obfuscated and divided such that identifiers and personal information are only held locally and the unique identifier of the data is without any linkage to the personal information stored locally).
Accordingly, it would have been obvious to modify MacCarthy in view of Mawdsley before the effective filing date with a reasonable expectation of success. One would have been motivated to make the modification in order to safeguard personal data to comply with mandated privacy laws (e.g., see [0009] of Mawdsey).
As to claim 2, the rejection of claim 1 is incorporated. MacCarthy further teaches determining that the second region is distinct from and outside the first region, wherein the first region and the second region are governed by different data anonymization regulations (e.g., see [0023] wherein the system can be implemented across different countries or geographical regions with varying regulations).
As to claim 3, the rejection of claim 1 is incorporated. MacCarthy-Mawdsley further teaches wherein the anonymized data is decoupled from patient-identifiable information prior to being received at the second location (e.g., see [0023], [0034] of MacCarthy teaching de-identification of healthcare data, de-identification including removing personal identifying information. See also [0046] of Mawdsley wherein encryption techniques occur prior to data transmission).
As to claims 9-11 the claims are directed to the system implementing the method of claims 1-3 and further recites at least one data storage device physically located within a first region and storing instructions for cross-border transfer while preserving first data anonymization (e.g., see Abstract, Fig. 1, [0023]), are similarly rejected.
As to claims 17-19, the claims are directed to the non-transitory computer readable medium implementing the method of claims 1-3 and are similarly rejected.
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over MacCarthy and Mawdsley, as applied above, and in further view of Krishnapuram et al. (USPPN: 2014/0088989; hereinafter Krishnapuram).
As to claim 5, the rejection of claim 1 is incorporated. While MacCarthy teaches generating a report (see rejection above), which is consistent with at least [0110] of Applicant’s originally filed specification of supplement analysis, MacCarthy-Mawdsley fail to the analyzing comprising using machine learning algorithms trained on data of the permanent storage.
However, in the same field of endeavor of analyzing data, Krishnapuram teaches wherein the analyzing further comprises accessing the permanent storage to supplement the analysis of the anonymized data using machine learning algorithms trained on data of the permanent storage (e.g., see Abstract, [0018]. [0066] teaching the use of machine learning models to analyze local data).
Accordingly, it would have been obvious to modify MacCarthy-Mawdsley in view of Krishnapuram before the effective filing date of the application with a reasonable expectation of success. One would have been motivated to make the modification to provide rapid learning for making useful medical predictions for patient care while maintain privacy concerns (e.g., see [0002], [0006] of Krishnapuram).
As to claim 13 the claim is directed to the system implementing the method of claim 5 and is similarly rejected.
Claims 4, 6-8, 12, 14-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over MacCarthy and Mawdsley, as applied above, and in further view of Taylor (USPPN: 2012/0041739; hereinafter Taylor).
As to claim 4, the rejection of claim 1 is incorporated. While MacCarthy teaches the stored anonymized data includes diagnoses, patient visit information, drug data, procedure data, laboratory data, data feeds, test results, or other similar data (e.g., see [0027]), MacCarthy fails to explicitly teach wherein the stored health data retrieved from the permanent storage includes results of a patient-specific blood flow computation calculated at an earlier date. It is noted that the claim language of the anonymized data includes “results of a patient-specific blood flow computation calculated at an earlier date” is interpreted as nonfunctional descriptive information as they are not functionally required in the claimed method. See MPEP 2111.05. The function described in the claimed method would be performed the same regardless of whether the claimed results of a patient-specific blood flow computation calculated at an earlier date existed. Therefore, MacCarthy having taught the anonymized data includes any data related to or associated with the health of a person, teaches the claimed limitation. Furthermore, it would have been obvious to substitute any particular type of patient data to be included for the anonymized data as a simple substitution. As such, it would have been obvious before the effective date of the application to substitute the generic data related to the health of a person of the prior art with any specific blood flow computation because the results would have been predictable for easily identifying desired data). See KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740-41, 82 USPQ2d 1385, 1396 (2007); and MPEP 2143.
Nonetheless, for the purposes of compact prosecution and in the same field of endeavor of patient-specific health data, Taylor teaches wherein the analyzed data includes results of a patient-specific blood flow computation calculated at an earlier date (e.g., see Abstract, Fig. 2, [0108], [0270] wherein patient data can include previously calculated patient-specific blood flow). it would have been obvious to substitute any particular type of patient data to be included for the anonymized data as a simple substitution. As such, it would have been obvious before the effective date of the application to substitute the generic data related to the health of a person of the prior art with any specific blood flow computation because the results would have been predictable for easily identifying desired data). See KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740-41, 82 USPQ2d 1385, 1396 (2007); and MPEP 2143.
As to claim 6, the rejection of claim 2 is incorporated. While MacCarthy teaches analyzing anonymized data (see rejection above), MacCarthy fails to teach prompting refining of modeling techniques available at the second region, based on the analyzed data.
However, in the same field of endeavor of patient-specific health data, Taylor teaches prompting refining of modeling techniques available at the second region, based on the analyzed data (e.g., see Abstract, [0197], [0269] teaching determining cardiovascular information which includes the ability to refine blood flow modeling with the motivation of providing feedback before medical decisions are made). Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified MacCarthy so as to have included the ability to refine blood flow modeling, in accordance with the teaching of Taylor, in order to provide feedback before medical decisions are made since so doing could be performed readily and easily by any person of ordinary skill in the art, with neither undue experimentation, nor risk of unexpected results (e.g., see [0269]).
As to claim 7, the rejection of claim 1 is incorporated. MacCarthy fails to teach generating, using the analysis server, an anatomical model of a patient based on the stored health data and conducting a patient-specific computation through the generated anatomical model; and determining, using the analysis platform, a patient-specific blood flow computation in the patient based on the generated anatomical model and a mass or a volume of a myocardial tissue of the patient.
However, in the same field of endeavor of patient-specific health data, Taylor teaches generating, using a remote data analysis server, an anatomical model of a patient based on the stored health data and conducting a patient-specific computation through the generated anatomical model (e.g., see [0106]-[0108], [031]-[0134] teaching the use of models to perform patient-specific blood flow analysis including generation of anatomical models); and determining, using the remote data analysis server, a patient-specific blood flow computation in the patient based on the generated anatomical model and a mass or a volume of a myocardial tissue of the patient (e.g., see [0107], [0112], [0113] wherein the blood flow computation is based on the anatomical model and other characteristics of the patient include volume of blood flow from the heart, myocardial mass, etc.).
Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified MacCarthy in view of Taylor so as to have included the ability to create a three-dimensional model of a patient’s heart and interactive report images, in order to analyze blood flow characteristics using a patient-specific three dimensional model and improve the accuracy of the blood flow modelling and provide information resulting from the analysis since so doing could be performed readily and easily by any person of ordinary skill in the art, with neither undue experimentation, nor risk of unexpected results (e.g., see Taylor, Abstract, [0264], [0265]).
As to claim 8, the rejection of claim 1 is incorporated. MacCarthy fails to teach wherein the analyzing further comprises: determining a format of the anonymized data; selecting a predetermined analysis type from a plurality of available analysis types for use in analyzing the anonymized data based on the determined format of the anonymized data; and generating a model based on the determined analysis type.
However, in the same field of endeavor of patient-specific health data, Taylor teaches wherein the analyzing further comprises: determining a format of the anonymized data; selecting a predetermined analysis type from a plurality of available analysis types for use in analyzing the anonymized data based on the determined format of the anonymized data; and generating a model based on the determined analysis type (see 112 rejection above. e.g., see also [0219], [0238]-[0243], [0246]-[0248], [0253] wherein type of data is used to generate the model for analysis. See also rejection above wherein the data is anonymized).
Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified MacCarthy in view of Taylor so as to have included the ability to create a three-dimensional model of a patient’s heart and interactive report images, in order to analyze blood flow characteristics using a patient-specific three dimensional model and improve the accuracy of the blood flow modelling and provide information resulting from the analysis since so doing could be performed readily and easily by any person of ordinary skill in the art, with neither undue experimentation, nor risk of unexpected results (e.g., see Taylor, Abstract, [0264], [0265]).
As to claims 12 and 14-16, the claims are directed to the system implementing the method of claims 4 and 6-8 and are similarly rejected.
As to claim 20, the claim is directed to the non-transitory computer readable medium implementing the method of claim 4 and is similarly rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STELLA HIGGS whose telephone number is (571)270-5891. The examiner can normally be reached Monday-Friday: 9-5PM.
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/STELLA HIGGS/Primary Examiner, Art Unit 3681
