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 .
Priority
Priority Claims PRO 63/688,610 08/29/2024 is acknowledge.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/01/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 5-15 objected to because of the following informalities “patent” interpreted as patient according claims context. 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 1-20 are rejected under 35 U.S.C. § 101 because the claims recite a mental-process abstract idea, do not integrate that exception into a practical application, and do not add significantly more.
Step 1
Claims 1-20 are evaluated under Step 1 to determine whether each claim, considered as a whole, falls within a statutory category.
Claims 1-10 recite systems comprising components configured to perform functions and therefore fall within the machine category. Claims 11-20 recite methods comprising acts and therefore fall within the process category.
Accordingly, claims 1-20 satisfy Step 1 and are evaluated under Step 2A, Prong One.
Step 2A, Prong One
Prong One asks only whether the claim recites a judicial exception, here claims 1-20 recite organizing, retrieving, and presenting device-indexed medical records, a mental-process abstract idea.
Independent Claims Analysis
Representative Claim 1
Non-bold language identifies the asserted judicial exception. Bold language identifies additional elements reserved for Prong Two.
A system comprising:
[1] at least one registry comprising a plurality of accounts, each account of the plurality of accounts being associated with a respective implanted medical device of a plurality of medical devices, wherein each account of the plurality of accounts comprises data associated with the respective implanted medical device, wherein the data associated with the respective implantable medical device comprises:
[2] device information; and
[3] patient information that is associated with a patient within whom the implantable medical device is implanted; and
[4] a medical device identifier configured to:
[5] receive a signal from a particular implanted medical device of the plurality of medical devices;
[6] retrieve one or more of the data associated with the account of the particular implanted medical device; and
[7] provide an output indicative of the one or more of the data associated with the account of the particular implanted medical device that is implanted within the patient.
Claims 1 and 11 are grouped because both recite device-indexed accounts, retrieval of data associated with the account corresponding to a particular implanted device, and an output indicating the retrieved data. The differences do not change the shared Prong One information-organization and retrieval analysis.
Under the broadest reasonable interpretation, the non-bold language organizes device and patient records into accounts indexed by implanted device, selects information from the account corresponding to a particular device, and identifies the selected information as the content indicated by an output.
The non-bold part limitations [1-3] and [6], and the non-bold portion of [7] recite a mental process. Organizing device and patient records into device-associated accounts requires recognizing and recording informational relationships. Retrieving data from the corresponding account requires locating and selecting records using the particular device as the index. The non-bold portion of [7] merely identifies the selected information indicated by the output. These operations are observations and evaluations practically performable through human thought aided by paper records. MPEP § 2106.04(a)(2)(III)
A person could maintain a paper registry containing labeled folders, each representing an account associated with a respective implanted device and containing its device and patient information. The person could recognize the corresponding label, locate the folder, inspect its entries, and select the relevant data. Generic database software or hardware performs the same non-bold organization, lookup, and selection electronically do not overcome prong one.
Dependent Claims Analysis
The dependent claims do not change the Prong One result. Their added limitations merely narrow the same device-indexed organization, selection, retrieval, and presentation of medical-device information recited in the independent claims.
Claims 3, 4, 5, 10, 13, 14, and 15 narrow the registry organization or account content; claims 9 and 20 add retrieval or selection by data type. These limitations remain mental organization and selection of records. Claims 6 and 16 add medical-event recordkeeping, likewise performable using written records. Claims 2, 7, 8, 12, 17, 18, and 19 add API access, location, display, or upload implementations but no new exception beyond the inherited mental process.
Accordingly, claims 1-20 recite a mental-process abstract idea under Step 2A, Prong One. The identified additional elements proceed to Prong Two for practical-application analysis.
Step 2A, Prong Two
Prong Two asks whether the non-exception claim elements, individually and as an ordered combination, apply the abstract idea in a meaningful technological or practical way rather than merely limiting it to a field, gathering data, using a tool, or reporting the outcome.
The additional elements of claims 1-20 do not integrate the recited mental process into a practical application because they use conventional hardware to receive identifying information, perform the abstract registry lookup, and present the result.
Independent Claims Analysis
Claim 1 and 11 adds the medical device identifier, receiving a signal from the particular implanted medical device, and providing an output.
Individual Additional Elements Evaluation
The system or method form merely places the abstract process within a statutory claim category. The medical device identifier and receiving a signal from a particular implanted medical device supply hardware and input used to perform the abstract account lookup. The providing an output limitation merely presents the result. These elements do not improve the operation of the identifier, implanted device, registry, computer, or network, and do not effect a treatment or transformation. They therefore amount to instructions to apply the abstract idea using hardware as a tool and insignificant data gathering or result presentation under MPEP §§ 2106.05(f) and 2106.05(g).
Combination Additional Elements Evaluation
In combination, the additional elements receive information, use hardware to perform the abstract registry lookup, and present the result. The combination does not change how the hardware operates or otherwise integrate the abstract idea into a practical application.
Dependent Claims Analysis
No dependent claim integrates the exception. Claims 2 and 12 add API access without an API architecture, authentication operation, security mechanism, or changed computer operation does not improve any technology under MPEP 2106.05(a). Claims 7 and 18 add medical-care locations, restricting only the field of use under MPEP 2106.05(h). Claims 8 and 19 add a display and displaying the retrieved information, which report the result under MPEP 2106.05(g). Claim 17 adds uploading by the medical device identifier without a technical transmission mechanism under MPEP 2106.05(a). As established in Prong One, claims 3-6, 9, 10, 13-16, and 20 add only narrower record organization, content, selection, or recordkeeping within the exception and therefore add no element for separate Prong Two treatment.
Accordingly, the additional elements of claims 1-20, individually and in the claimed combinations, do not integrate the mental process into a practical application. The claims proceed to Step 2B.
Step 2B
The identified additional elements are reevaluated individually and as the actual ordered combinations to determine whether they provide an inventive concept amounting to significantly more than the mental process. Here, they merely perform conventional signal receipt, registry access, retrieval, and output functions using known hardware, so claims 1-20 do not amount to significantly more than the mental process.
Independent Claims Analysis
Individual Additional Elements Evaluation
The additional elements do not individually provide an inventive concept. The system or method form adds no inventive function. The medical device identifier, signal receipt, registry access, and output operation are recited at the level of ordinary functional results. The Specification describes an instrumentation amplifier “known in the art,” any suitable signal converter, established communication channels, “databases known in the art,” networking environments that are “conventional and commonplace,” and Internet protocols “well-known in the art.” Applicant’s Specification [0057], [0059], [0089], [0119], [0122], [0135]. These express statements support the WURC finding under MPEP § 2106.05(d). That section also identifies receiving or transmitting data, electronic recordkeeping, and storing or retrieving information as conventional functions when claimed at this generality. As Alice explains, requiring “a generic computer to perform generic computer functions” supplies no inventive concept. The signal receipt and output operation also remain insignificant pre-solution and post-solution activity under § 2106.05(g).
Combination Additional Elements Evaluation
Considered together, the additional elements use known hardware and communication functions according to their established purposes to implement the abstract registry lookup. The claims identify no unconventional hardware arrangement, improved hardware operation, or other technical feature beyond using those components to receive information and provide the lookup result. The combination therefore does not provide significantly more than the abstract idea.
Dependent Claims Analysis
No dependent claim supplies an inventive concept. Claims 2 and 12 use API access only as the registry-access conduit. Claims 7 and 18 add medical-care locations. Claims 8 and 19 use a display for post-solution presentation. Claim 17 uses the admitted database and network functions for uploading. Claims 3-6, 9, 10, 13-16, and 20 add no additional element beyond the exception identified in Prong One. None requires the signal-derived identity, signal-controlled query, or technical arrangement absent from the independent claims.
Claims 1-20, considered individually and as ordered combinations, do not amount to significantly more than the recited mental process. Claims 1-20 are therefore ineligible and rejected under 35 U.S.C. § 101.
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, 7, and 8 and Claims 11, 13–15, 18, and 19 are rejected under 35 U.S.C. § 102(a)(1) as anticipated by Stevenson, US 2006/0212096 A1.
Claim 1.
Stevenson teaches,
A system comprising:at least one registry comprising a plurality of accounts, each account of the plurality of accounts being associated with a respective implanted medical device of a plurality of medical devices, wherein each account of the plurality of accounts comprises data associated with the respective implanted medical device, wherein the data associated with the respective implantable medical device comprises: device information; and patient information that is associated with a patient within whom the implantable medical device is implanted; ( Stevenson, par. 0055, 0076-0077)
Stevenson teaches RFID interrogator and computer database identify implanted medical devices and maintain device-linked records. The database functions as the claimed registry because it stores multiple records keyed to each device’s unique code, model number, or serial number. Each record includes the required device and patient information, including model, serial number, lead-system data, patient identity/contact information, medical condition, treatment, and history.and
a medical device identifier configured to:receive a signal from a particular implanted medical device of the plurality of medical devices; (Stevenson, the electromagnetic return signal 28 is detected by the interrogator 20 and presented as a digital code sequence, 0075, 0055, 0057).
Stevenson embeds the RFID tag in the AIMD header block, and the tag emits a digitally modulated return pulse detected by the interrogator. Thus, the signal originates from a component of the particular implanted medical device.
retrieve one or more of the data associated with the account of the particular implanted medical device; (Stevenson, the digital code from the RFID tag 12 … enters automatically … into the computer system 60 to immediately get a download, 0076).andprovide an output indicative of the one or more of the data associated with the account of the particular implanted medical device that is implanted within the patient. (Stevenson, permit direct display of all of the information contained on the RFID tag 12, 0075; immediately get a download of AIMD and patient information, 0076).
Claim 3.
Stevenson teaches,
The system of claim 1, wherein the at least one registry comprises an electronic health registry anda device registry. (Stevenson, database … including … patient and physician information, and patient history and National Cardiovascular Data Registry … three national registries … and the ICD Registry, 0076).
Claim 4.
Stevenson teaches,
The system of claim 3, wherein the account of the device registry comprises one or more of a device demographic or a lead assessment. (Stevenson, model and serial number of the AIMD, lead wire system, 0076; full database by model numbers and serial numbers of medical implantable devices, 0077)
Claim 5.
Stevenson teaches,
The system of claim 1, wherein the account of the at least one registry comprises one or more of:a patent demographic, an episode of care, a risk factor, a comorbidity, a diagnostic study, a lab date, an intra- or post-procedure event, a discharge status, or a discharge medication. (Stevenson, patient history when available and ICD Registry … collects detailed information on ICD implantations, 0076)
Claim 7.
Stevenson teaches,
The system of claim 1, wherein the medical device identifier is provided at one of:a hospital, an emergency department, an imaging center, or an ambulance. (Stevenson, the physician or emergency room personnel may obtain the digital code from the RFID tag 12, 0076).
Claim 8.
Stevenson teaches,
The system of claim 1, wherein the medical device identifier comprises a display, wherein the medical device identifier is configured to provide the output indicative of the one or more of the data associated with the account of the particular implanted medical device that is implanted within the patient by displaying on the display the one or more of the data. (Stevenson, interrogator 20 may comprise programmer or programmer/reader, which would permit direct display of all of the information contained on the RFID tag 12, 0075)
Note: Claims 11, 13–15, 18, and 19 are rejected with claims 1, 3–5, 7, and 8;
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 2, 6, 9, 10,12, 16- 17, and 20 are rejected under 35 U.S.C. § 103 as unpatentable over Stevenson, US 2006/0212096 A1, in view of Raduchel et al., US 2017/0161439 A1.
Claim 2
Stevenson teaches,
The system of claim 1, wherein the medical device identifier is configured to access the at least one registry via an application programming interface (API); (Stevenson, computer system 60 which may be linked to the worldwide web and RFID tag could also access the … National Cardiovascular Data Registry, 0076).
Stevenson discloses accessing an online registry through an integrated computer system, but does not identify an API or disclose API-mediated registry requests.
Raduchel teach that One exemplary interface for accessing a record storage system is an application program interface API and that the mobile device utilizes the API to securely authenticate and then obtain electronic medical record data. Raduchel 0226. Raduchel further exposes a healthcare-record database through an API. Raduchel 0226, 0309.
A POSITA would have combined before filling date, Stevenson with Raduchel by programming computer 60 to send Raduchel’s authenticated API request, carrying Stevenson’s RFID-derived device code, to the registry and process the response. Stevenson seeks to immediately get a download; Raduchel’s device uses the API to securely authenticate and then obtain medical-record data.
Claim 6.
Stevenson teaches,
The system of claim 1, wherein the medical device identifier is configured to cause the at least one registry to store information associated with a medical event. (Stevenson, a physician may use an external programmer or interrogator 20 to write additional patient information to the RFID tag 12, 0075; ICD Registry … collects detailed information on ICD implantations, 0076).
Stevenson separately teaches writing medical information to a read/write RFID tag and storing implantation information in an ICD Registry. It does not connect those teachings by disclosing that the interrogator causes the registry to store medical-event information.
Raduchel teaches a user electronic device generating medical records from follow-up visits and sensor readouts and transmitting a new electronic record to a database provider, whose record-storage system stores it. Raduchel 0112–0113. A send-to-database control causes the record to be sent to a database provider to store the new medical record. Raduchel 0120. Raduchel identifies visit, admission, and discharge events, stores all discrete event data in the healthcare database, and teaches that Transmission and storage of event data may use electronic-medical-record standards. Raduchel 0218, 0225–0226, 0309, 0314.
Before the effective filing date, a POSITA would have combined Stevenson with Raduchel by programming interrogator 20 and computer 60 to create an event record, associate it with Stevenson’s RFID digital number, and send it to Stevenson’s registry for storage using Raduchel’s record-add transaction. Stevenson states that its database is very difficult to keep updated with current patient and physician information. Stevenson 0077. Raduchel’s device transmits a new record and the remote system stores it.
Claim 9
Stevenson teaches,
The system of claim 1, wherein the medical device identifier is configured to retrieve all of the data associated with the account of the particular implanted medical device; and permit a user to search by data type all of the data associated with the account of the particular implanted medical device; (Stevenson, immediately get a download, including all of the information required as to the model and serial number of the AIMD, lead wire system, patient and physician information, and patient history, 0076).
Stevenson retrieves a substantial device-specific information set, but all of the information required does not necessarily mean every item associated with the database account. Stevenson also searches the database by the unique device code, not by data type.
Raduchel et al. teach an electronic device that, upon user input, requests records from each identified storage system and aggregates them into a complete set of medical records. Raduchel 0129–0131. The device groups the aggregated data into categories such as heart or medicine; selecting a displayed category presents the records in that category, enabling relevant records to be identified without having to review a full set. Raduchel 0148. It also organizes the complete set by category and filters records using user-defined filter criteria. Raduchel 0159. These teachings supply complete-set retrieval and user searching by data category.
Before the effective filing date, a POSITA would have combined Stevenson with Raduchel by programming computer 60, after identifying the account with the RFID code, to retrieve every registry record for that account, assemble the complete set, and expose Raduchel’s category selection or user-defined filter. This uses a known technique to improve a similar healthcare-record device under MPEP §2143.I.C. Stevenson seeks immediate access to diverse device and patient information; Raduchel’s grouping lets a provider identify relevant records without reviewing the full set. Conventional database aggregation, classification, and filtering would predictably produce the claimed complete, searchable device-account record. Stevenson, 0076–0077; Raduchel 0129–0131, 0148, and 0159.
Claim 10
Stevenson teaches,
The system of claim 9, wherein the data type comprises one or more of device information or patient information; (Stevenson, model and serial number of the AIMD, lead wire system, patient and physician information, and patient history, 0076).
Claim 17.
Stevenson teaches,
The method of claim 16, wherein adding information associated with the medical event to the at least one registry comprises uploading the information associated with the medical event by the medical device identifier. (Stevenson, use an external programmer or interrogator 20 to write additional patient information to the RFID tag 12; immediately get a download, [0075]–[0076])
Stevenson writes patient information from the interrogator to the RFID tag and downloads database information to the computer. It does not disclose the identifier uploading medical-event information into the registry.
The Raduchel teaches the missing registry-upload technique and event-record content. Its user device receives new-record information identifying treatment and type, updates local or remote database information, receives a new medical record based on treatment or diagnosis, and may transmit the new electronic record to a database provider. The record is then sent to a record storage system over a network for archival storage. Raduchel paragraphs 0104-0107, 0113, and 0120.
A POSITA would have combined Stevenson with Raduchel before the effective filing date by programming Stevenson’s web-linked, integrated interrogator and computer to transmit a treatment- or diagnosis-based event record to Stevenson’s database, using the already-read RFID digital number as the registry key. Stevenson identifies the reason: its local database is very difficult to keep updated with current patient and physician information. Stevenson paragraph 77. Raduchel supplies the applicable instruction: transmit the new electronic record to a database provider. Raduchel paragraph 113. Existing web connectivity and record transmission make the modification compatible, preserve established functions.
Claim 20.
Stevenson teaches,
The method of claim 11, further comprising searching the one or more of the data
associated with the account of the particular implanted medical device by data type. (Stevenson, download … model and serial number … lead wire system, patient and physician information, and patient history; full database by model numbers and serial numbers, [0075]–[0077])
Stevenson retrieves multiple kinds of information but describes no search.
The Raduchel reference teaches the missing type-based technique in a comparable medical-record device. After receiving records, the device displays a listing that may be organized by type, provider and/or date, and a user may browse the electronic records using the listing to display a record of interest. Raduchel paragraph 0086. The device also identifies records of a certain type and provides type-restriction controls. Raduchel paragraphs 81 and 97.
A POSITA would have combined Stevenson with Raduchel before the effective filing date by adding Raduchel’s type-organized listing and browse-select routine to Stevenson’s web-linked computer after retrieval from the database all keyed to the digital information transmitted by the RFID tag. Raduchel states that treatment or diagnosis of the user may be improved through timely access and permits only a subset of the medical records of the user related to treatment. Raduchel paragraphs 0039-0040.
Note: Claims 12 and 16 restate the API-access and registry-storage limitations of claims 2 and 6 as method steps; the same Stevenson–Raduchel modifications therefore apply.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DAMIAN RUIZ whose telephone number is (571)272-0409. The examiner can normally be reached 0800-1800.
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/J.D.R./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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