DETAILED ACTION
Notices to Applicant
This communication is a final rejection. Claims 1-20, as filed 09/01/2026, are currently pending and have been considered below.
Priority is generally acknowledged to 17/554,714 which was filed 12/17/2021.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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The double patenting rejections are withdrawn in view of the terminal disclaimer filed 09/01/2026.
The claim objections are withdrawn.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-8, 10-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mao (US20180301205A1) in view of Obst (US20130197935A1 – cited in Applicant’s IDS from 10/10/2025).
Regarding claim 1, Mao discloses:
--based on unstructured criteria data expressed as a plurality of values, each value being associated with a data value type, encoding, by at least one healthcare provider computing device, based on an encoding rule and corresponding data value type, a first portion of the unstructured criteria data as encoded data values (“The structuralizer 102 is configured to convert input non-structured data into structured data. An example of non-structured data is the following sentence “John Doe is a six foot tall sixty years old.” In one non-limiting instance, structuralizing this sentence would produce the following structured data: name=John Doe; height=6′0″; age=60,” [0015]; “the structuralizer 102 employs natural language processing (NLP) and comprises modules for language identification (a language identifier 202), tokenization (a tokenizer 204), part-of-speech (POS) annotation (a POS annotator 206), parsing (a shallow parser 208), a name entity identification (a name entity annotator 210), and information extraction (an information extraction 212),” [0018]; [0047]-[0048]);
--formatting, based on a formatting rule and corresponding data value type, a second portion of the unstructured criteria data as formatted data values (expressing values according to their type as “height=6′0″; age=60… the structuralizer 102 employs a predetermined data model to analyze non-structured data and organize certain content in the non-structured data (name, height and age in the above example) into known data elements.” [0015]);
--generating, based on a clinical trial and a concatenation of the encoded data values and the formatted data values, a clinical trial protocol data structure, wherein the encoding rule, the formatting rule, and the unstructured criteria data are associated with the clinical trial (“The trial data includes trial criteria 112 stored in a trial DB 114. Trial criteria 112 includes eligibility criteria such as age, gender, medical history, current health status, particular type and stage of some disease condition, molecular features, (e.g. mutations, expressions,—well-structured), etc. Clinical trial data are publicly available through government agencies, etc. Structuralized patient data and clinical trial data are respectively stored in a structured PHR DB 116 and a structured trial DB 118,” [0017]; concatenating data elements in [0015] into “the following structured data: name=John Doe; height=6′0″; age=60”);
Mao does not expressly disclose but Obst teaches:
--storing, in at least one database, the clinical trial protocol data structure, wherein the at least one database is accessible by at least one service provider computing device associated with the at least one healthcare provider computing device (“The candidate identification apparatus 102 may be embodied as any computing device or combination of a plurality of computing devices configured to identify candidates for a clinical study in accordance with one or more example embodiments. In this regard, by way of non-limiting example, the candidate identification apparatus 102 may be embodied as one or more desktop computers, one or more laptop computers,” [0019]; [0020]; “the candidate identification unit 218 may be configured to access electronic prescription claims information that may be sent from a computerized pharmacy management system 104 to a payor system 108 over the pharmacy transaction telecommunication switch apparatus 106,” [0034]); and
--causing, based on a patient query data structure associated with a patient, a notification to be sent to at least one device associated with the patient, wherein the patient query data structure is received via the at least one service provider computing device, and wherein the notification is indicative of the patient query data structure matching the clinical trial protocol data structure (“identifying one or more prospective candidates for the clinical study at least in part by analyzing the electronic prescription transaction information to determine at least one patient having prescription history satisfying the study criteria set,” [0005]; “an automated call may be placed to the candidate. As another example, the candidate identification unit 218 may prompt a user of the candidate identification apparatus 102 to follow-up with the candidate, such as by causing display of a notification on a display of the user interface 216, emailing an individual tasked with contacting the candidate, and/or the like,” [0055]. This is viewed in light of Mao’s notification in [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to expand Mao’s clinical matching functions to include the computer architecture and match notifications of Obst because identifying and recruiting patients through this provider channel “may yield a better pool of candidates for a clinical study than existing direct-to-consumer strategies that are not targeted to individuals having a medical history indicative that they may be qualified for the study,” [0004].
Claims 8 and 15 are substantially similar to claim 1. The Examiner further notes that Mao discloses in [0024]: “Returning to FIG. 1, it is to be understood that the system 100 and/or a sub-set of its components (e.g., the structuralizer 102, the semantic matcher 122, the ranking engine 126, etc.) can be implemented by a computer(s) with at least one processor (e.g., a microprocessor, a central processing unit, a controller, etc.) configured to execute at least one computer readable instruction stored in non-transitory computer readable storage medium (which excludes transitory medium) such as physical memory and/or other non-transitory medium.”
Regarding claims 3, 4, 10, 11, 17, and 18, Mao in view of Obst discloses: wherein the patient query data structure is indicative of a plurality of attributes associated with the patient, and wherein the plurality of attributes are encoded according to the encoding rule (and formatting rule). Mao applies the identical structuralizer to the patient data in [0016]-[0020]: “the structuralizer 102 structuralizes patient data and trial data…The structuralizer 102 employs the data in the OT DB 120 to structuralize the patient data and the clinical trial data.” Because the same encoding/formatting operations and the same ontology/terminology are applied to the patient attributes as to the criteria, the patient attributes are encoded and formatted according to those same rules.
The motivation to combine is the same as in claim 1.
Regarding claims 5, 12, and 19, Mao in view of Obst discloses: determining, by the at least one service provider computing device, based on the patient query data structure and the clinical trial protocol data structure stored in the at least one database, that the patient may be a candidate for participation in the clinical trial. Obst’s provider candidate identification apparatus “identif[ies] one or more prospective candidates for the clinical study at least in part by analyzing the electronic prescription transaction information to determine at least one patient having prescription history satisfying the study criteria set” in [0005]. Mao likewise discloses that “the semantic matcher 122 employs a search engine to match patient data and clinical trial data and hence patients and clinical trials” in [0020].
The motivation to combine is the same as in claim 1.
Regarding claims 6 and 13, Mao in view of Obst discloses: matching patient data, associated with the patient query data structure, with one or more portions of data associated with the clinical trial. Mao’s semantic matcher “matches patient information stored in the structured PHR DB 116 and the clinical trial information stored in the structured trial DB 118” in [0020].
The motivation to combine is the same as in claim 1.
Regarding claims 7, 14, and 20, Mao in view of Obst discloses: wherein the notification is received by the at least one device associated with the patient via the at least one service provider computing device. Obst’s provider apparatus causes the notification to be received by the patient’s device: “the invitation may comprise an outbound call that may be placed to the prospective candidate” in [0044].
The motivation to combine is the same as in claim 1.
Claims 2, 9, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mao in view of Obst and Milian (“Formalization of clinical trial eligibility criteria: Evaluation of a pattern-based approach” - cited in Applicant’s IDS from 10/10/2025).
Regarding claims 2, 9, and 16, Mao discloses: wherein the formatting rule specifies how to express a value based on a data value type (e.g., [0015]). Mao does not expressly disclose but Milian teaches: wherein the encoding rule specifies how to express a value as a regular expression based on corresponding data value type (“It is based on detecting in text semantic entities (diseases, treatment, measurements etc.) using ontology annotators and semantic taggers, and detecting predefined patterns providing the contextual information in which these entities occur,” Abstract).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the clinical trial matching platforms of Mao and Obst to include the predefined text matching patterns of because this would enable “automatically extracting their meaning and evaluating them for a particular patient” and thus improve the automation and accuracy of the matching. Milian Abstract.
Response to arguments
Applicant's arguments filed 09/01/2026 have been fully considered but are not persuasive
Applicant argues that Mao performs “applies one conversion that treats all extracted values identically” and that “[n]othing in Mao divides the input into a first portion to be encoded under an encoding rule and a different second portion to be formatted under a formatting rule.” Remarks 8-9. The claims do not require that the encoding rule and the formatting rule be different rules, that the operations must differ, or that a selection is made between them based on value type. Instead, they require (1) that a first portion of values be expressed as encoded data values based on an encoding rule and the corresponding data value type and (2) that a second portion be expressed as formatted data values based on a formatting rule and the corresponding data type. Mao teaches both. Mao’s model resolves one portion of the values to known data elements, i.e., “name=John Doe”, through name entity identification and information extraction described above, e.g., Mao [0018]. Mao teaches the second portion in the form dictated by its syntax, i.e., “height=6’0”; age=60”. The claimed elements are met by Mao’s single component performing both operations.
Further, Mao’s structuralizer does not treat every value “identically”. Instead its output for one trial arm expresses each criterion in the form its type calls for such as a diagnosis or mutation as a coded entity (e.g., “(3) BRAF V600E or BRAF V600K mutation” in [0048]) and a numeric criterion as a formatted comparison (e.g., “(11) QTc<470 msec” in [0048]). That example in [0048] shows the structuralizer producing both types of data from unstructured criteria text as the claim requires.
Applicant argues that the semicolons in Mao [0015] “are punctuation within an illustrative sentence in Mao's written description, not a disclosed step of combining encoded data values with formatted data values.” Remarks 9-10. Claim 1 generates, based on a clinical trial and a concatenation of the encoded data values and the formatted data values, a clinical trial protocol data structure. The parenthetical statement in the rejection describes Mao’s output, i.e., “name=John Doe; height=6′0″; age=60”, rather an any express concatenating step, which the claim does not require. Mao’s output is the encoded and formatted values joined in a single delimited structure which is generated and stored (i.e., DB 118 in [0017]).
Applicant argues that the Obst [0055] “is directed to the operator of the system, not to ‘at least one device associated with the patient’” and is not “a notification whose content is indicative of a match between a patient query data structure and a stored clinical trial protocol structure” Remarks 10-12. Obst teaches “an automated call may be placed to the candidate” in [0055]. Applicant appears to argue against Obst individually for this notification limitation rather than grappling with the combination of Mao and Obst. Mao provides the comparison of the patient to the clinical trial protocol structure, and Obst provides the notification to candidates in the case of a match. The combination provides the claimed limitation. One cannot show nonobviousness by attacking the references individually where the rejection is based on a combination of references. MPEP 2145(IV).
Applicant argues that “[b]ecause no such data structure exists in the cited art, neither reference can store it.” Remarks 12-13. This argument relies upon the arguments (a)-(c) above which are not persuasive. Mao stores the structured trial representation (i.e., DB 118 in [0017]), and Obst supplies the apparatus and networked access (i.e., [0019], [0020], [0034]).
Applicant argues that the asserted rationale “addresses the source of candidate data, not the claimed data structures or the claimed notification indicative of a match between those data structures.” Remarks 13-14. The benefit of Obst is provided by Obst’s statement of what it provides: “a relationship based identification and recruitment of candidates through the pharmacy channel,” [0004]. Trial recruitment through that channel is Obst’s patient-directed contact, and Obst states its object in the same paragraph: “The identified patients may be proactively targeted for participation in the clinical study,” [0004]. The rational therefore reaches the teaching for which Obst is relied on. The rationale to modify a reference need not be the same as Applicant’s reason. MPEP 2144(IV).
Applicant generally argues that the dependent claims are nonobvious, but this is not persuasive because the rejections of the independent claims are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624
