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 .
The following is a non-final, first office action on the merits, in response to application filed 12/8/2023. Claims 1-23 have been examined and are currently pending.
Priority
Acknowledgment is made of applicant's claim for a provisional application filed on 12/9/2022.
Claim Objections
Claim 16, 17 is objected to because of the following informalities:
Claim 16, 17 recites dependency of “method of claim 15”, but claim 15 is a system claim.
Appropriate correction is required.
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 1-26 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.
Alice Corp. also establishes that the same analysis should be used for all categories of claims, regardless of a system/apparatus, a method, or a product claim.
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. The claim(s) recite(s) abstract ideas including “Certain Methods of Organizing Human Activity”, “an idea of itself”, “mental process” which have been identified/found by the courts as abstract ideas in new 101 memos of the subject matter eligibility in here (https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility) including 2019 Revised Patent Subject Matter Eligibility Guidance. This judicial exception is not integrated into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because It/they is/are recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications:
Independent claim 1 (Step 2A, Prong I): is directed to multiple abstract ideas including “Certain Methods of Organizing Human Activity”, “an idea of itself”, and “Mental process”.
Claim 1, Steps of,
extracting an image of a source document included in the electronic health record and creating one or more snippets, wherein the one or more snippets includes data elements;
selecting one or more of the snippets;
recognizing one or more data elements from the one or more snippets;
inputting one or more of the recognized data elements into an Application Programming Interface (API);
creating one or more search terms using the one or more recognized data elements;
searching an Electronic Health Record (EHR) using the API for one or more search terms;
identifying one or more data elements in the EHR as corresponding to the one or more search terms; and
presenting the one or more identified elements to a user.
falls within “Certain Methods of Organizing Human Activity” grouping of abstract idea because these steps mainly describe an idea itself. For example, a person may follow rules or instructions to observe/extract an image from the document, observe/select/input data, observe/recognize/identify data elements, observe/create search terms/EHR, observe/present/display data to a user.
In addition, claim 1, steps mentioned above also falls within the abstract
“Mental Processes” grouping of abstract ideas since these limitation covers performance of the limitations in the mind or by paper and pen. For example, observe/extract an image from the document, observe/select/input data, observe/recognize/identify data elements, observe/create search terms/EHR, observe/present/display data to a user.
Further, steps of (“inputting….”, “presenting…”) are considered as “insignificant extra-solution activity” to the judicial exception since they are merely receiving/collecting/displaying/providing data/presenting data.
Independent claim 1, Step 2A (Prong II): Accordingly, the claim recites an abstract idea(s) as pointed out above. This judicial exception(s) is/are not integrated into a practical application. In particular, the claim recites additional element (a database) that are not significant more than the abstract ideas. The instant steps are not actually performed by a machine or a computer. Nothing in the claim element precludes the step from practically being performed in the mind, and is simply organized information through human activity or merely mental tasks, and is part of, or a related, judicial exception and does not meaningfully limit the application of the identified judicial exception, and as such does not constitute significantly more.
There is no specificity regarding any technology, just broadly, execute the programming instructions to collect data, receive/generate data, identify data, searching data. The steps are mainly receiving data, generating/creating data, identifying data, searching data, and displaying data. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Accordingly, there is neither improvement to another technology or technical field nor an improvement to the functioning of the computer itself, and does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Independent claim 1, (step 2B):
Accordingly, the claim recites an abstract idea(s) as pointed out above. There are no additional elements in claim 1 actually perform the steps. The additional element (“a database”), is recited at a high level of generality, and add nothing of substance to the underlying abstract idea; thus, they are not significantly more than the identified abstract idea.
In light of the specification, ([0036, 0037]), the components are merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic computer/device components recited as performing generic computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/transmit/display information does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in claim 1).
According to MPEP 2106.05 (d), elements that the Courts have recognized as well-understood, routine, conventional activity in particular fields are e.g., "Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward
information); Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93” (evidence required by Berkeimer memo). Further, according to Berkheimer memo 04/19/2018, section III.A.1, “A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or 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 35 U.S.C. § 112(a)”.
Dependent claims 2-11, are merely add further details of the abstract steps/elements recited in claim 1 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Therefore, dependent claims 2-11 are also non-statutory subject matter.
Independent claim 12, 23: Alice Corp. also establishes that the same analysis should be used for all categories of claims. Therefore, independent system/apparatus claim 12 and 23 are also rejected as ineligible subject matter under 35 U.S.C. 101 for substantially the same reasons as the method claim(s) 1.
Further, the components (i.e., a processor, a system, a database) described in independent claims 12, 23, add nothing of substance to the underlying abstract idea. Similarly, as it relates to the computer system claims, the limitations appear to be performed by a generic computing system/device. These components are merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic computer components recited as performing generic computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/access/identify/search/transmit/send/display information over communication network/internet does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in claim 1).
According to MPEP 2106.05 (d), elements that the Courts have recognized as well-understood, routine, conventional activity in particular fields are e.g., "Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward
information); Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93” (evidence required by Berkeimer memo). Further, according to Berkheimer memo 04/19/2018, section III.A.1, “A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or 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 35 U.S.C. § 112(a)”.
Applicant’s Specification, [0036, 0037] indicate a general-purpose computer perform the instant steps and demonstrates the well-understood, routine, conventional nature of the information processing device (a processor/a memory/a computer) in any computing implementation. Thus, evidence has been provided to show these additional elements are well-understood, routine, conventional activity according to Berkheimer memo. Therefore, for the above mentioned reasons, viewed as a whole, even in combination, the above steps do not amount to significantly more/do not provide an inventive concept.
Dependent claims 13-22, are merely add further details of the abstract steps/elements recited in claim 12, without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Therefore, dependent claims 13-22 are also non-statutory subject matter.
Viewed as a whole, the claims (1-23) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
Thus, the claims do NOT recite limitations that are “significantly more” than the abstract idea because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment.
Thus, the claimed invention, as a whole, does not provide 'significantly more' than the abstract idea, and is non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mohan et al. (hereinafter, Mohan, US 2022/0351810).
As per claim 1, 12, 23, Mohan discloses a method, a computerized system, a computer processor, for mapping a database field having data elements in an electronic health record to a question on a clinical trial case report form (CRF), comprising:
at least one processor having a snippet tool (Fig. 2, item 260, [0017,0035, 0045])
extracting an image of a source document included in the electronic health record and creating one or more snippets, wherein the one or more snippets includes data elements (Fig. 4, item 404, 406, 408, [0028, 0029, 0045, 0057]);
selecting one or more of the snippets ([0030, 0045]);
recognizing one or more data elements from the one or more snippets ([0045, 0057]);
inputting one or more of the recognized data elements into an Application Programming Interface (API) ([0030, 0035]);
creating one or more search terms using the one or more recognized data elements ([0034]);
searching an Electronic Health Record (EHR) using the API for one or more search terms ([0031,0053]);
identifying one or more data elements in the EHR as corresponding to the one or more search terms ([0048, 0049]); and
presenting the one or more identified elements to a user (Fig. 3C, [0057, 0059]).
As per claim 2, 13, Mohan further discloses, wherein the step of creating the one or more snippets further comprises:
storing the source document image ([0034, 0042]);
determining one or more desired inputs to the Case Report Form (CRF) ([0036, 0048, 0058]);
identifying one or more hotspots in the source document image comprising key words associated with the one or more desired inputs to the CRF ([0045, 0046]);
confirming the accuracy of the hotspot as an appropriate input to the CRF ([0040, 0046, 0052]); and
designating the hotspot as a snippet ([0038]).
As per claim 3, 14, Mohan further discloses, wherein each of the recognized one or more data elements comprises a predefined label corresponding to the desired input of the CRF ([0035, 0048, 0049]).
As per claim 4, 15, Mohan further discloses, further comprising adjusting the hotspot to include a data value associated with the predefined label Fig. 3C, ([0042, 0045, 0049, 0053]).
As per claim 5, 16, Mohan further discloses, wherein the adjusting of the hotspot is performed by a user ([0042, 0053, 0060]).
As per claim 6, 17, Mohan further discloses, wherein the adjusting of the hotspot is performed automatically by a processor ([0035]).
As per claim 7, 18, Mohan further discloses, further comprising
confirming a match between the one or more presented identified elements and a corresponding one or more data elements from the snippet ([0045, claim 6]).
As per claim 8, 19, Mohan further discloses, further comprising,
extracting one or more identifiers from the EHR that includes the confirmed one or more matched elements ([0034; and
storing the one or more identifiers as corresponding to a desired input to the CRF ([0034]).
As per claim 9, 20, Mohan further discloses, further comprising,
employing the one or more stored identifiers and corresponding CRF input to correlate a desired input from an EHR to a similar desired input to another CRF element ([0030, 0038, 0048, 0049, 0057]).
As per claim 10, 21, Mohan further discloses, further comprising,
retaining the one or more stored identifiers and corresponding CRF input at a remote storage location ([0034, 0035]); and
accessing the retained stored identifiers and corresponding CRF input for use by a second user ([0034, 0042, 0060]).
As per claim 11, 22, Mohan further discloses, further comprising, wherein the second user is located at a remote location from the first user ([0033]).
The prior art made of record and relied upon is considered pertinent to applicant’s disclosure.
Virkar et al. (US 2019/0156927, describes managing medical research data, processing medical research records in a respective data format obtained via a respective interchange mechanism).
Sethumadharan et al. (US 2023/0143557, providing contextually bundle data elements into work items, and contextually configure workflows enables users of such a system significant flexibility in their ability to identify patients with specific diagnosed ailments, enhanced coder efficiency, and larger reimbursements from Medicare or other insurer).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN M LI whose telephone number is (571)270-5489. The examiner can normally be reached on Mon-Thurs, 8:30am--5pm. Fax is 571-270-6489.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi, can be reached on 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUN M LI/
Primary Examiner, Art Unit 3685
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