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 .
Applicant’s amendments and remarks filed on 08/10/2026 have been fully considered.
Claims 2-21 are pending for examination. Claim 1 is cancelled.
Priority
It is noted that the supports for “initiate, with the wireless transceiver, a telemedicine session with the clinician over the network to obtain a diagnosis based on the first and second measured physiological parameters” can only be found in the specification of US Application No. 15/681,256, and the effective filing date is 08/18/2017. In addition, the supports for “request for at least one patient ID associated with a user; receive an input including the at least one patient ID; validate the at least one patient ID… determine critical congenital heart defect (CCHD) screening information based at least in part on the first and second measured physiological parameters; and transmit, via the wireless transceiver, the CCHD screening information in association with the validated at least one patient ID, over a network to a gateway computing device” can be found in the specification of US Provisional Patent Application No. 62/685834, and the effective filing date is 06/15/2018.
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 2-3, 6-9, and 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kiani (USPGPUB 2008/0071155 – applicant cited), in view of Loffredo et al. (USPGPUB 2006/0180659), and further in view of Rose et al. (USPGPUB 2018/0192965 – applicant cited). In regard to claims 2, 14 and 17, Kiani discloses a system and a method for noninvasively measuring a physiological parameter of a user to facilitate a diagnosis (Figs. 3-8 and associated descriptions), the system comprising: an electronic device (elements 300, 410, 510, and 610, Figs. 3-8 and associated descriptions) comprising a display (element 382, Fig. 3 and associated descriptions), a wireless transceiver ([0033]), a memory device (storing, [0015]) comprising processor-executable instructions stored thereon, and one or more hardware processors in communication with the display, the wireless transceiver, and the memory device; the one or more hardware processors programmed to execute the processor-executable instructions stored in the memory device (Figs. 3-8 and associated descriptions) to: display, on the display, instructions to obtain a first measurement by positioning a first noninvasive sensor at a first measurement site on the user (block 715, Fig. 7A and associated descriptions); receive, from the first noninvasive sensor, first signals responsive to a first physiological characteristic of the user (block 730, Fig. 7A and associated descriptions); calculate a first measured physiological parameter responsive to the first signals (blocks 730 and 732, Fig. 7A and associated descriptions); display, on the display, instructions to obtain a second measurement by positioning a second noninvasive sensor at a second measurement site on the user (block 735, Fig. 7A and associated descriptions); receive, from the second noninvasive sensor, second signals responsive to a second physiological characteristic of the user (block 750, Fig. 7A and associated descriptions); calculate a second measured physiological parameter of the user responsive to the second signals (blocks 750 and 755, Fig. 7A and associated descriptions); display, on the display, the first and second measured physiological parameters (blocks 732, 755, 787, and 792, Figs. 7A-7B and associated descriptions) and determine critical congenital heart defect (CCHD) screening information based at least in part on the first and second measured physiological parameters (step 794, Figs. 7A-7B and associated descriptions; CHD diagnostics 803, Fig. 8 and associated descriptions).
Kiani does not specifically disclose display, on the display, a request for at least one patient ID associated with a user; receive an input including the at least one patient ID; validate the at least one patient ID by applying one or more validation rules or formulas to the at least one patient ID to determine whether the at least one patient ID has one or more patient ID characteristics defined for a healthcare site at which the user is screened.
Loffredo teaches a medical system/ method (Figs. 1-9 and associated descriptions) comprises display, on the display, a request for at least one patient ID associated with a user (prompts the user to scan the chosen patient's wrist barcode identification, [0081]; Fig. 9 and associated descriptions); receive an input including the at least one patient ID (user scans the patient's wrist barcode identification, [0081]; Fig. 9 and associated descriptions); validate the at least one patient ID using one or more validation rules by applying one or more validation rules or formulas to the at least one patient ID to determine whether the at least one patient ID has one or more patient ID characteristics defined for a healthcare site at which the user is screened (whether a patient is scanned that exist in the system within the location/ the patient's name on the Patient List/ If the user scans a different patient's wristband, the user will be alerted with the following warning message on the handheld: "The patient identified {Name} is different from the selected patient. Please recheck {Name} order(s)." In another case, if the user scans the wristband of a patient that does not exist in the system or does not have any collections pending within the location, the following warning message is displayed on the handheld: "Patient Not Identified, [0081]; It is implicit that at least a comparison/ validation process is performed to see whether the scanned patient's wrist barcode identification matches to the ID for the chosen patient’s name in the list).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method (Kiani) to incorporate the patient ID validating and associated functions/ steps as taught by Loffredo, since both devices are medical systems and one of ordinary skill in the art would have recognized that validate of patient ID facilitate checking whether the patient exist in the system with in the location and prevent performing medical examining procedure to the wrong patient. The rationale would have been to prevent performing medical examining procedure to the wrong patient.
Kiani as modified by Loffredo does not specifically disclose transmit, via the wireless transceiver, the CCHD screening information in association with the validated at least one patient ID, over a network to a gateway computing device (claims 2 and 17); and initiate, with the wireless transceiver, a telemedicine session with the clinician over the network to obtain a diagnosis based on the first and second measured physiological parameters (claim 14).
Rose teaches a telemedicine system with vital sign monitoring devices (Figs. 1- 18 and associated descriptions) comprises a wireless transceiver ([0008]; [0010]; [0032]; elements 125, 135 and 194, Figs. 1 and 4-8 and associated descriptions); a pulse oximeter (element 180, Figs. 1 and 4-8 and associated descriptions) and blood pressure sensor (element 90, Fig. 1 and 4-8 and associated descriptions) and transmit, with the wireless transceiver, measured parameters/ information, in association with the at least one patient ID, over a network to a gateway computing device (elements 105, 120, 125, 130, 135, and 150, Fig. 1 and associated descriptions; internet gateway, [0056]; [0074]; Fig. 10 and associated descriptions); and initiate, with the wireless transceiver, a telemedicine session with the clinician over the network to obtain a diagnosis based on the measured vital signs/ parameters (element 500, Figs. 5-6 and associated descriptions; [0034]; [0086]; [0116- 0178]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method (Kiani as modified by Loffredo) to incorporate the wireless transmission of determined medical data/ information and the telemedicine functions as taught by Rose, since both devices are vital sign monitoring devices and one of ordinary skill in the art would have recognized that telemedicine/ video conference with medical professional facilitate obtain diagnosis/ analysis of measured vital signs/ physiological measurements (see Rose) when the doctor is not present in the measuring site. The rationale would have been to obtain real-time diagnosis/ analysis for remote medical professionals.
In regard to claims 3 and 18, Kiani as modified by Loffredo and Rose discloses the first and second noninvasive sensors are the same noninvasive sensor (Fig. 4 and associated descriptions of Kiani).
In regard to claim 6, Kiani as modified by Loffredo and Rose discloses the first or second measured physiological parameters include at least one of: oxygen saturation, blood pressure, or temperature ([0012]; [0047] of Kiani).
In regard to claim 7, Kiani as modified by Loffredo and Rose discloses the CCHD screening information is communicated, in association with the validated at least one patient ID, from the gateway computing device to a data aggregator computing device (elements 130, 625, 640, 648, and/or 658, Figs. 1 and 6 and associated descriptions of Rose).
In regard to claims 8 and 19, Kiani as modified by Loffredo and Rose discloses in response to receiving a message indicating a need to re-screen a user, display a notification (re-run one or both of the first and second measurements, “...it is envisioned that one professional may perform a real-time examination using the MedWand system and upon examination of the “live” data, request a secondary professional to “log on” and review/manage the session with the user. The ability to timely add a second professional to the session, one who may ask the user to perform certain examination- specific follow on actions, for a more extensive evaluation”, [0034]: “The ability for the doctor/professional to engage in real-time with the patient and “conduct” an examination via the user's simple manipulation of the MedWand device, having integrated sensors, and also examine the sensor data (live or historical) in a secure environment”, [0080]: “For example, either the doctor or the patient may want to measure the patient's pulse SpO2, and finger temperature. The “Pulse” button/action is selected on the computing device. A help screen appears to guide the patient through proper usage or set-up for each test’, [0082]; “If connected to a health care profession during a real-time teleconference the patient can elect to share all of the vital information as it is collected real-time simply by pressing the “share live” button on the interface. The doctor can also direct the patient/ caregiver for proper readings and even invoke some of the tests remotely’, [0087]; [0102] of Rose).
In regard to claims 9 and 20, Kiani as modified by Loffredo and Rose discloses the message is received via the data aggregator computing device, and wherein the data aggregator computing device determines the message is to be provided to the system (Figs. 1, 5-15 and associated descriptions of Rose).
In regard to claims 13 and 21, Kiani as modified by Loffredo and Rose discloses output a selection of clinicians, receive a selection of one of the clinicians from the user, and initiate a communication session with the clinician ([0094-0095]; Figs. 5-15 and associated descriptions of Rose).
In regard to claim 15, Kiani as modified by Loffredo and Rose discloses the telemedicine session comprises a video of the clinician ([0056]; [0088] of Rose).
In regard to claim 16, Kiani as modified by Loffredo and Rose discloses instruct the user to perform at least one of the first measurement or the second measurement again (referring to claim 8 above) and measuring signal quality of the measurements ([0015-0016] of Kiani) but does not specifically the re-run the first or second measurements due to low signal confidence in the at least one of the first measurement or the second measurement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method to show the signal quality of the first and second measurements to the medical professional(s) and allow them to instruct the user to re-perform the measurements. The rationale would have been to obtain more reliable physiological measurements.
Claim 5 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kiani, Loffredo and Rose, as applied to claims 2-3, 6-9, and 13-21 above, and further in view of Parker (USPGPUB 2012/0254966 – cited in previous action). In regard to claim 5, Kiani as modified by Loffredo and Rose discloses the one or more hardware processors are programmed to execute the processor-executable instructions stored in the memory device to further: in response to determining that the at least one patient ID is not valid, provide a notification to the user ([0081] of Loffredo) but does not specifically disclose allow the user to bypass the notification and proceed with measurements despite determining that the at least one patient is not valid.
Park teaches authentication function ([0101-0104]) comprises to allow the user to bypass the notification and proceed with operations despite determining that the at least one patient is not valid (in the event of a failed authentication, the user may be provided with an option to bypass the authentication and provide a password to gain access…, [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method (Kiani as modified by Loffredo and Rose) to incorporate the bypass function(s) and associated functions as taught by Park, since both devices comprises authentication functions and one of ordinary skill in the art would have been recognized that if the user enters incorrect patient ID but remembers the correct password or being granted a bypass password, the user should still be able to use the device. The rationale would have been to bypass failed authentication and use a bypass password to gain access for using the device when the user forgets the patient ID number.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kiani, Loffredo and Rose, as applied to claims 2-3, 6-9, and 13-21 above, and further in view of Ofek et al. (USPGPUB 2012/0215560 – applicant cited). In regard to claim 10, Kiani as modified by Loffredo and Rose discloses storing the patient data in servers/ database (Figs. 1 and 6 and associated descriptions of Rose) but does not specifically disclose the data aggregator computing device is configured to de-duplicate patient data.
Ofek teaches a solution for medical databases ([0030]) comprises de-duplicate patient data ([0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system (Kiani as modified by Loffredo and Rose) to incorporate the de-duplicate function as taught by Ofek, since both systems are for medical database and one of ordinary skill in the art would have recognized that de-duplicate facilitate to cleanse duplicate patent records. The rationale would have been to cleanse duplicate patent records from the database.
In regard to claim 11, Kiani as modified by Loffredo, Rose and Ofek discloses the data aggregator computing device is configured to transmit at least the CCHD screening information in association with the validated at least one patient ID to an electronic medical record (EMR) system or other database system (Fig. 6 and associated descriptions of Rose).
In regard to claim 12, Kiani as modified by Loffredo, Rose and Ofek discloses aggregate patient data from a plurality of computing devices (Fig. 6 and associated descriptions of Rose).
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 2, 6-17 and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,172,890 in view of Rose. In regard to claims 2, 6-17 and 19-21 of present application, claims 1-24 of ‘890 recite all the claimed limitations except transmit, via the wireless transceiver, at least the first and second measured physiological parameters, in association with the at least one patient ID, over a network to a clinician; and initiate, with the wireless transceiver, a telemedicine session with the clinician over the network to obtain a diagnosis based on the first and second measured physiological parameters.
Rose teaches a telemedicine system with vital sign monitoring devices (Figs. 1- 18 and associated descriptions) comprises a wireless transceiver ([0008]; [0010]; [0032]; elements 125, 135 and 194, Figs. 1 and 4-8 and associated descriptions); a pulse oximeter (element 180, Figs. 1 and 4-8 and associated descriptions) and blood pressure sensor (element 90, Fig. 1 and 4-8 and associated descriptions) and transmit, with the wireless transceiver, the first and second measured parameters, in association with the at least one patient ID, over a network to a clinician (elements 105, 120, 125, 130, 135, and 150, Fig. 1 and associated descriptions; [0074]; Fig. 10 and associated descriptions); and initiate, with the wireless transceiver, a telemedicine session with the clinician over the network to obtain a diagnosis based on the measured vital signs/ parameters (element 500, Figs. 5-6 and associated descriptions; [0034]; [0086]; [0116- 0178]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method (claims 1-24 of ‘890) to incorporate the wireless transmission of medical data and the telemedicine functions/steps as taught by Rose, since both devices are vital sign monitoring devices and one of ordinary skill in the art would have recognized that telemedicine/ video conference with medical professional facilitate obtain diagnosis/ analysis of measured vital signs/ physiological measurements (see Rose). The rationale would have been to obtain real-time diagnosis/ analysis for remote medical professionals.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,004,881. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of ‘881 anticipate or recite similar limitations as claims 2-21 of present application.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if overcome the double patenting rejection and rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not teach or suggest “receive an input including the at least one patient ID; validating the at least one patient ID using one or more validation rules, wherein the one or more validation rules comprise at least one of: checking for correct checksum values, checking for certain digits being within allowable ranges, or checking for a correct format” in combination with the other claimed elements/ steps.
Response to Arguments
Applicant’s arguments, see page 7 of Remarks, filed on 08/10/2026, with respect to claim 17 have been fully considered and are persuasive. The objection of claim 17 has been withdrawn.
Applicant’s arguments, see page 7 of Remarks, filed on 08/10/2026, with respect to claims 2-16 have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 2-16 has been withdrawn.
Applicant’s arguments, see pages 10-15 of Remarks, filed on 08/10/2026, with respect to claims 2-21 have been fully considered and are persuasive. The 35 USC 101 rejections of claims 2-21 has been withdrawn.
Applicant’s amendment and argument with respect to claims 2 and 17 filed on 08/10/2026 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
In regard to the double patenting rejections, applicant does not provide any arguments and requests the rejections to be maintained. In response, the DP rejections are maintained for the reason of records.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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