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 .
Status of Claims
This action is in reply to the application filed on 07/28/25.
Claims 1-20 are currently pending and have been examined.
Continuity/Priority Date
Status of this application as a Continuation of US Application 17/215,545 filed 03/29/21 (US Patent 12,394,521 issued 08/19/25), is acknowledged. Applicant’s priority claim to U.S. Provisional Patent Application 63/112,418, filed 11/11/2020, is acknowledged. Accordingly, a priority date of 11/11/2020 has been given to this application.
Abstract Objections
The abstract of the disclosure is objected to because it appears to be a carry-over from the Abstract of the parent application (US Application 17/215,545), which is directed to a “method” while the instant independent claim is directed to a “system”. Further, the language of the Abstract uses the terms first device, second device, and third device, whereas the instant independent claim does not utilize these terms but rather uses the terms wearable sleep test device, healthcare administrator device, and manufacturer device. Examiner recommends updating the Abstract to disclose a “system” to align with the scope of independent Claim 1 and update the terminology of the various devices to reflect the device terminology used in the present claims. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5, 7, 9 rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 2-6, 8-11, 23 of U.S. Patent No. 12,394,521.
Claims 1-3, 5, 7, 9 recite substantially similar limitations as Claims 1, 2-6, 8-11, 23 of U.S. Patent No. 12,394,521. The subject matter of the instant application amounts to claim limitations which are slightly broader in scope than U.S. Patent No. 12,394,521. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims recite the same or substantially similar limitations, but Claim 1 of the instant application is directed to “a system for securely transferring medical data from a sleep test” whereas Claim 1 (representative) of US Patent No. 12,394,521 is directed to “a method for securely transferring medical data from a sleep test” and Claim 6 of US Patent No. 12,394,521 is directed to “a non-transitory computer readable medium having stored thereon instructions for causing a processing circuitry to execute a process for securely transferring medical data for a sleep test. Examiner has bolded the portions of the claims that recite the same or substantially similar limitations in the table below. Further, the instant application amounts to limitations that are slightly broader in scope: For example, both instant application 19/282,015 and US Patent 12,394,521 recite similar limitations pertaining to the wearable sleep test device being configured to store the medical data in at least one designated storage location (e.g., instant application recites “the wearable sleep test device is further configured to store the medical data in at least one designated storage location” and US Patent 12,394,521 recites “configuring the wearable sleep test device to store the medical data in at least one designated storage location”), while Patent 12,394,521 positively recites additional step of storing the data: storing, by the wearable sleep test device, the medical data in the at least one designated storage location. Similarly, US Patent 12,394,521 recites “capturing, by the at least two sensors of the wearable sleep test device, the medical data during the sleep test by generating, by the finger probe, a signal from a finger of a patient, and generating, by the chest sensor, one or more measurements of movement of a torso of the patient while instant application 19/282,015 more broadly recites “wherein the wearable sleep test device is configured to: generate, by the finger probe during the sleep test, a signal from a finger of a patient; and generate, by the chest sensor during the sleep test, one or more measurements of movement of a torso of the patient”.
Dependent Claims 2-3, 5, 7, 9 recite substantially similar limitations as Claims 2-5, 8-11, 23 of U.S. Patent No. 12,394,521. The only differences are addressed above with respect to the differences between the corresponding independent claims (e.g., system vs. method/non-transitory computer readable medium).
Instant Application 19/282,015
U.S. Patent No. 12,394,521
Claim 1: A system for securely transferring medical data for a sleep test, comprising: a wearable sleep test device having an embedded unique identifier and comprising at least two sensors comprising a finger probe and a chest sensor; a healthcare administrator device; and a manufacturer device configured to: receive a patient key associated with the wearable sleep test device from the healthcare administrator device, wherein the wearable sleep test device is configured to: generate, by the finger probe during the sleep test, a signal from a finger of a patient; and generate, by the chest sensor during the sleep test, one or more measurements of movement of a torso of the patient, wherein the manufacturer device is further configured to: receive, from the wearable sleep test device, a request to store medical data based on the signal generated by the finger probe and the one or more measurements of movement of the torso generated by the chest sensor, wherein the wearable sleep test device is further configured to: store the medical data in at least one designated storage location, wherein each of the at least one designated storage location is accessible to the wearable sleep test device and to the healthcare administrator device, and wherein the manufacturer device is further configured to: send the at least one designated storage location and the embedded unique identifier to the healthcare administrator device
Claim 1: A method for securely transferring medical data for a sleep test, comprising: receiving, at a manufacturer device, a patient key associated with a wearable sleep test device from a healthcare administrator device, the wearable sleep test device having an embedded unique identifier and comprising at least two sensors comprising a finger probe and a chest sensor, capturing, by the at least two sensors of the wearable sleep test device, the medical data during the sleep test by generating, by the finger probe, a signal from a finger of a patient, and generating, by the chest sensor, one or more measurements of movement of a torso of the patient; receiving, at the manufacturer device, a request to store the medical data captured by the at least two sensors, the medical data comprising the signal generated by the finger probe and the one or more measurements of movement of the torso generated by the chest sensor, from the wearable sleep test device; configuring the wearable sleep test device to store the medical data in at least one designated storage location, wherein each of the at least one designated storage location is accessible to the wearable sleep test device and to the healthcare administrator device; storing, by the wearable sleep test device, the medical data in the at least one designated storage location; and sending, by the manufacturer device, the at least one designated storage location and the embedded unique identifier to the healthcare administrator device
Claim 1: A system for securely transferring medical data for a sleep test, comprising: a wearable sleep test device having an embedded unique identifier and comprising at least two sensors comprising a finger probe and a chest sensor; a healthcare administrator device; and a manufacturer device configured to: receive a patient key associated with the wearable sleep test device from the healthcare administrator device, wherein the wearable sleep test device is configured to: generate, by the finger probe during the sleep test, a signal from a finger of a patient; and generate, by the chest sensor during the sleep test, one or more measurements of movement of a torso of the patient, wherein the manufacturer device is further configured to: receive, from the wearable sleep test device, a request to store medical data based on the signal generated by the finger probe and the one or more measurements of movement of the torso generated by the chest sensor, wherein the wearable sleep test device is further configured to: store the medical data in at least one designated storage location, wherein each of the at least one designated storage location is accessible to the wearable sleep test device and to the healthcare administrator device, and wherein the manufacturer device is further configured to: send the at least one designated storage location and the embedded unique identifier to the healthcare administrator device
Claim 6: A non-transitory computer readable medium having stored thereon instructions for causing a processing circuitry to execute a process for securely transferring medical data for a sleep test, the process comprising: receiving, at a manufacturer device, a patient key associated with a wearable sleep test device from a healthcare administrator device, the wearable sleep test device is a sleep test device having an embedded unique identifier and comprises at least two sensors comprising a finger probe and a chest sensor; capturing, by the at least two sensors of the wearable sleep test device, the medical data during the sleep test by generating, by the finger probe, a signal from a finger of a patient, and generating, by the chest sensor, one or more measurements of movement of a torso of the patient; receiving, at the manufacturer device, a request to store the medical data captured by the at least two sensors, the medical data comprising the signal generated by the finger probe and the one or more measurements of movement of the torso generated by the chest sensor, from the configuring the wearable sleep test device to store the medical data in at least one designated storage location, wherein each of the at least one designated storage location is accessible to the wearable sleep test device and to the healthcare administrator device; storing, by the wearable sleep test device, the medical data in the at least one designated storage location; and sending, by the manufacturer device, the at least one designated storage location and the embedded unique identifier to the healthcare administrator device
Depending Claims
Instant Application 19/282,015
U.S. Patent No. 12,394,521
Claim 2
Claim 23
Claim 3
Claims 2, 8
Claim 5
Claims 3, 9
Claim 7
Claims 4, 10
Claim 9
Claims 5, 11
Subject Matter Eligibility under 35 USC 101: Claims 1-20 are subject matter eligible. The claims are understood to amount to a specific computerized system utilizing multiple electronic devices (a wearable sleep test device having an embedded unique identifier and comprising at least two sensors comprising a finger probe and a chest sensor; a healthcare administrator device; and a manufacturer device), in which the wearable sleep test device generates a signal by a finger probe and generates measurement(s) of movements of a torso of the patient by a chest sensor; the manufacturer device receives, from the wearable sleep test device, a request to store medical data based on the signal generated by the finger probe and the one or more measurements of movement of the torso generated by the chest sensor; the wearable sleep test device stores the medical data in at least one designated storage location, wherein each of the at least one designated storage location is accessible to the wearable sleep test device and to the healthcare administrator device, and the manufacturer device sends the at least one designated storage location and the embedded unique identifier to the healthcare administrator device, which cannot reasonably be considered abstract consistent with USPTO guidance.
Subject Matter Free of the Prior Art: The closest prior art is understood to be Ramabadran (US Publication 20190365315A1), which is directed to a system and method for conducting a sleep test for screening for obstructive sleep apnea. Ramabadran teaches on the broadest reasonable interpretation of the limitations pertaining to a wearable sleep test device comprising at least two sensors comprising a finger probe and chest sensor, wherein the wearable sleep test device is configured to: generate, by the finger probe during the sleep test, a signal from a finger of a patient; and generate, by the chest sensor during the sleep test, one or more measurements of movement of a torso of the patient (paras. [0039] and [0041]). Ramabadran further teaches on a healthcare administrator device (See Fig. 2 and para. [0035], physician 202) and a manufacturer device (See Fig. 2 “mobile computer” 204/”provider 204” where provider is understood to provide the device to the patient and as such is interpreted as being synonymous with manufacturer). While Ramabadran teaches on sleep lab personnel providing a “unique security key” for a patient and texting/emailing the key directly to the patient, Ramabadran does not teach on the limitation of “a manufacturer device configured to: receive a patient key associated with the wearable sleep test device from the healthcare administrator device”. Ramabadran teaches on transmitting data acquired from a sleep test to a cloud environment (e.g., a “storage location”) and teaches on the provider receiving the data at the conclusion of the sleep test, but does not teach on the limitations pertaining to, “wherein the wearable sleep test device is further configured to: store the medical data in at least one designated storage location, wherein each of the at least one designated storage location is accessible to the wearable sleep test device and to the healthcare administrator device, and wherein the manufacturer device is further configured to: send the at least one designated storage location and the embedded unique identifier to the healthcare administrator device”.
Other remarkable prior art includes Donnelly et. al. (US Publication 20180014779A1), directed to a wearable medical monitoring device which may be used for detecting sleep apnea and includes a wearable device with a fingertip pulse oximeter to generate a physiological signal and sensors placed on the subject’s torso and chest, in which sensed data can be transmitted over a network to a doctor on demand or as part of a periodic report for the doctor to evaluate the data and make a diagnosis.
The closest non-patent literature is understood to be the article “What to Know About an At-Home Sleep Test” which teaches on an at-home sleep test method which utilizes a sleep test device with finger and chest sensors to detect breathing patterns of the wearer, but does not teach on any of the particulars of the instant invention with respect to transmission of data between manufacturer, wearable sleep test, and healthcare provider devices or configuration of storage.
A search of publicly available prior art fails to yield a reference or combination of references that would make the claimed combination of limitations in Claim 1 obvious when considered as a whole.
Conclusion
In the interest of expediting prosecution, Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20150164410A1, directed to sleep apnea syndrome screening using wearable devices
US Publication 20140257833A1, directed to a cloud-based system for remote medical checkups and physician managed biometric data which may be used to enable physicians to remotely analyze a patient’s data to detect a sleep disorder
US Patent 11202603B1, directed to a method and device for sleep analysis for testing of sleep disorders such as sleep apnea using physiological sensors applied to the finger and torso of the subject
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNE-MARIE K ALDERSON whose telephone number is (571)272-3370. The examiner can normally be reached on Mon-Fri 9:00am-5:00pm EST and generally schedules interviews in the timeframe of 2:00-5:00pm EST.
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682
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