DETAILED ACTION
This action is made in response to the communication filed on December 27, 2024. This action is made non-final.
Claims 1-20 are pending. 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 .
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-8 recite a method of anonymizing patient data, which is within the statutory category of a process. Claims 9-16 recite a system for anonymizing patient data, which is within the statutory class of a machine. Claims 17-20 recites a non-transitory computer readable memory performing instructions for anonymizing patient data, which is within the statutory class of a manufacture.
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability. Alice Corp. v. CLS Bank Int'l, 573 U.S. ___ (2014). Claims 1-20, each considered as a whole and as an ordered combination, are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
MPEP 2106 Step 2A – Prong 1:
The bolded limitations of:
Claims 1, 9, and 17 (claim 1 being representative)
receiving, via a data storage device, anonymized data from a first region; determining an identifier associated with the anonymized data; retrieving, from the data storage device, stored health data associated with the determined identifier; analyzing, via an analysis platform, the anonymized data based on the stored health data associated with the determined identifier; generating, via the analysis platform, a report of the analyzed anonymized data; and transmitting, via the analysis platform, the report to a downstream entity located in the first region.
as presently drafted, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions). For example, but for the noted computer elements, the claim encompasses a person following rules or instructions in which information is communicated between people in different regions. The examiner further notes that “methods of organizing human activity” includes a person’s interaction with a computer (see October 2019 Update: Subject Matter Eligibility at Pg. 5). If the claim limitation, under its broadest reasonable interpretation, covers managing persona behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
MPEP 2106 Step 2A – Prong 2:
This judicial exception is not integrated into a practical application because there are no meaningful limitations that transform the exception into a patent eligible application. The additional elements merely amount to instructions to apply the exception using generic computer components (“a storage device”, "a non-transitory computer readable medium”, “a processor” —all recited at a high level of generality). Although they have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." (See MPEP 2106.04(d)(I) indicating mere instructions to apply an abstract idea does not amount to integrating the abstract idea into a practical application). Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
The “analysis platform” is not a generic computer component; however it is recited at a high levels of generality and similarly amount to generally linking the abstract idea to a particular technological environment. (See MPEP 2106.04(d)(I) indicating generally linking an abstract idea to a particular technological environment does not amount to integrating the abstract idea into a practical application).
The claims only manipulate abstract data elements as part of performing the abstract idea. They do not set forth improvements to another technological field or the functioning of the computer itself and instead use computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above. 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. Their collective functions merely provide conventional computer implementation. None of the additional elements recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
At the levels of abstraction described above, the claims do not readily lend themselves to a finding that they are directed to a nonabstract idea. Therefore, the analysis proceeds to step 2B. See BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed. Cir. 2016) ("The Enfish claims, understood in light of their specific limitations, were unambiguously directed to an improvement in computer capabilities. Here, in contrast, the claims and their specific limitations do not readily lend themselves to a step-one finding that they are directed to a nonabstract idea. We therefore defer our consideration of the specific claim limitations’ narrowing effect for step two.") (citations omitted).
MPEP 2106 Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the same reasons as presented in Step 2A Prong 2. Moreover, the additional elements recited are known and conventional generic computing elements (“a storage device”, "a non-transitory computer readable medium”, “a processor”—see Specification [0043] describing the various components as general purpose, common, standard, known to one of ordinary skill, and at a high level of generality, and in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy the statutory disclosure requirements). Therefore, these additional elements amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept that amounts to significantly more. See MPEP 2106.05(f).
The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, translating, and displaying data—see Specification above as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions).
Furthermore, as discussed above, the additional element of a “analysis platform” is recited at high levels of generality and were determined to generally link the abstract idea into a particular technological environment or field of use. This additional element have been re-evaluated under step 2B and have also been found insufficient to provide significantly more. (See MPEP 2106.05(A) indicating generally linking an abstract idea to a particular technological environment does not amount to significantly more). Furthermore, the Applicant’s Specification (e.g., see [0040], [0042], [0112]) indicates that the analysis platform includes cloud platforms systems that are well-understood, routing, and conventional in the field. (See MPEP 2106.05(I)(A) indicating that well-understood, routine, and conventional activities cannot provide significantly more)
Dependent Claims
The limitations of dependent but for those addressed below merely set forth further refinements of the abstract idea without changing the analysis already presented. Claims 2 (10, 18) merely recites differing privacy regulations of different regions amounts to different manners in which analysis would be conducted, claims 3 (11, 19) merely recite decoupling the data from identifiable information, 4 (12, 20) merely recite the type of data, and claims 5 (13) merely recite anonymizing the report, claims 6, 7 (14, 15) merely recite using an anatomical model to compute blood flow, which covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions).
Claims 8 (16) further refine the abstract idea described in the independent claim and further recite the use of hashing, which is a well-known approach to removing or privatizing data (e.g., see [0069] of MacCarthy). See MPEP 2106.05(I)(A) indicating that well-understood, routine, and conventional activities cannot provide significantly more
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, 8-11, 13, 16, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over MacCarthy et al (USPPN: 2016/0147945; hereinafter MacCarthy).
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, 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);
retrieving, from the data storage device, stored health data associated with the determined identifier (e.g., see [0040], [0044], [0045] 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, 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 (e.g., see Fig. 4, [0046], [0080] wherein the report is sent to a requesting entity).
As to claim 2, the rejection of claim 1 is incorporated. MacCarthy further teaches determining a second region that 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 further teaches wherein the health data is decoupled from patient-identifiable information (e.g., see [0023], [0034] teaching de-identification of healthcare data, de-identification including removing personal identifying information).
As to claim 5, the rejection of claim 1 is incorporated. MacCarthy further teaches wherein the report is 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).
As to claim 8, the rejection of claim 1 is incorporated. MacCarthy further teaches determining a hash associated with the analyzed anonymized data (e.g., see [0047], [0067], [0076], [0086] teaching utilizing hash tokens to define the anonymized patient identifier); and determining previously analyzed health data associated with either the analyzed anonymized data, based on a comparison of the hash to one or more stored hashes (e.g., see [0047], [0067], [0076], [0086] teaching matching the hash tokens the health data records).
As to claims 9-11, 13, and 16 the claims are directed to the system implementing the method of claims 1-3, 5, and 8 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.
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 4, 6, 7, 12, 14, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over MacCarthy, 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 analyzed anonymized data 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 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; 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.
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 claims 12 and 14-15, the claims are directed to the system implementing the method of claims 4 and 6-7 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
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