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 .
Claim Status
Claims 1-3, 5-13 and 15-24 are pending for examination.
Response to Arguments
Applicant's arguments filed 5/20/2026 have been fully considered but they are not persuasive.
In response to the arguments under “Rejection under 35 U.S.C. §103”, the newly introduced limitation in claims 1, 11 and 21 does not appear to overcome the teachings and suggestions of the prior arts by Yuds (Pat. No.: US 11,295,857 B1) in view of Albert (Pub. No.: US 2021/0280310 A1).
The newly introduced claim limitation “wherein, after the user feedback interface is engaged, the control unit performs the processing of the sound from the medical device into the machine sound information at a same time as or immediately following the processing of the voice input into the user feedback information, and wherein the user feedback information and the machine sound information are included together in a device status report that is transmitted to the remote system via the external network” in claim 1 and in corresponding claims 11 and 21 require the gateway device to collect the patient’s voice feedback and the machine sound information within substantially the same time frame and to transmit the collected information to a remote system.
However, Col. 9, line 52 - Col. 10 of Yuds discloses:
“In an implementation, when the patient 50 engages the instant user feedback interface 450, for example, by pressing an instant user feedback button on the gateway device 310, the patient 50 may be prompted by the system to provide the user feedback. The prompts may include automated questions audibly emitted from the gateway device 310 or other component, as further described in detail elsewhere herein. The patient's responses and other feedback may be transmitted over one or more networks using the connected health system 400 to a remote computer, server and/or location. At the same time as recording and/or transmitting the user feedback from the patient, the instant user feedback interface 450 may trigger the gathering of patient treatment and/or machine status information 460 from the dialysis machine 302 and/or any peripheral components connected thereto via the connection 301. This status information 460 may then be securely transmitted along with the user feedback information received from the patient 50 to the remote computer, server and/or location and thereby used to help understand the environment that caused the desire to provide user feedback. In one or more implementations, the status information 460 may include information about alarms on the dialysis machine 302, machine parameters, treatment details, status of supplies and/or other status information stored or available to the dialysis machine 302 at the time that the machine 302 is triggered via the user feedback interface 450 to provide the status information 460.” with emphasis underlined.
The cited section of the specification clearly teaches the gateway device collects the recording of the patient and the machine status information at the same time after the actuation of the feedback interface. The collected information is sent to a remote server. The gateway device receives the patient feedback via the microphone 430 and the machine status information 460 via a wireless connection 301.
Yuds fails to expressly teach the machine status information is received from at least one microphone configured to receive sound from the medical device; and process the sound from the medical device into transmissible machine sound information.
However, in the same field of medical system, Albert teaches a sound detector 40 that is configured to receive and identify the sounds generated by one or more medical devices 12, 18, 26, 28, 30 and to transmit the identified sound information to a remote server. See Abstract, “A system for detecting medical audio alarms. The system includes a detector and a server. The detector further comprises a microphone that is configured to receive a sound of the alarm; a microcontroller configured to determine an alarm pattern from the sound and to compare the determined alarm pattern to a plurality of patterns stored in a memory to identify a cause of the alarm; and a network interface configured to transmit the cause of the alarm. The server is configured receive the cause of the alarm and provide notification of the cause of the alarm.”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Yuds’s gateway device to receive and to identify sound outputted by the dialysis medical machine as taught by Albert to improve alarm sound identification.
In response to the arguments under “Non-Statutory Double Patenting”, the amendment fails to overcome the rejection. The pending claims remain unpatentable as obvious modifications of the patented claims of U.S. Patent No. 11,295,857 B1 in view of sound detector disclosed by Albert (Pub. No.: US 2021/0280310 A1). Additionally, a terminal disclose has not filed to overcome the rejection.
Therefore, the rejections are maintained based on the reasons provided.
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, 5-13 and 15-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,295,857 B1 in view of the sound detector disclosed by Albert (Pub. No.: US 2021/0280310 A1).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Regarding claims 1, 11 and 21, recite the limitation “the external network” in line 16 and the last line. There is insufficient antecedent basis for this limitation in the claim.
The limitation appears to refer to the limitation “a remote network that is external to the local network” in line 3 but lack the antecedent basis for an “external network”.
Please consider to amend appropriately.
Regarding claims 2-3, 5-10, 12-13, 15-20 and 22-24, are also rejected because these claims depend on claims, 1, 11 and 21 respectively.
Claim Rejections - 35 USC § 103
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 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 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, 5-13 and 15-24 are rejected under 35 U.S.C. 103 as being unpatentable over Yuds (Pat. No.: US 11,295,857 B1) in view of Albert (Pub. No.: US 2021/0280310 A1).
Regarding claim 1, Yuds teaches a user feedback system for a medical device (Health system 300-700, abstract), comprising:
a gateway device configured to connect to a local network of the medical device and configured to connect to a remote network that is external to the local network (Fig. 4, the gateway device 310 is connected to the local network 301 of the dialysis machine 302 and connected to the external network 311);
at least one microphone configured to receive audio input, wherein the audio input includes voice input from a user (Fig. 4, microphone 430) and machine status information from the medical device (Fig. 4, machine status information 460);
a user feedback interface communicatively coupled to the gateway device, wherein, when engaged, the user feedback interface causes activation of the at least one microphone to receive the voice input from the user and the machine status information from the medical device (Fig, 4, feedback interface 450, Col. 9, line 52- Col. 10, line14, “In an implementation, when the patient 50 engages the instant user feedback interface 450, for example, by pressing an instant user feedback button on the gateway device 310, the patient 50 may be prompted by the system to provide the user feedback. The prompts may include automated questions audibly emitted from the gateway device 310 or other component, as further described in detail elsewhere herein. The patient's responses and other feedback may be transmitted over one or more networks using the connected health system 400 to a remote computer, server and/or location. At the same time as recording and/or transmitting the user feedback from the patient, the instant user feedback interface 450 may trigger the gathering of patient treatment and/or machine status information 460 from the dialysis machine 302 and/or any peripheral components connected thereto via the connection 301.”. The gateway device 310 records the patient’s verbal response and the machine status information in response to the actuation of the feedback interface 450);
wherein the gateway device includes a control unit (Fig. 4 control unit 410), the control unit configured to:
process the voice input from the user into transmissible user feedback information;
process the machine status information from the medical device into transmissible machine information; and
transmit the user feedback information and the machine sound information to a remote system via the external network (Col. 2 line 15-30, “The gateway device includes a control unit that is configured to: process the voice input into transmissible user feedback information; obtain status information of the medical device via the local network; and transmit the user feedback information and the status information to a remote system via the external network.”),
wherein, after the user feedback interface is engaged, the control unit performs the processing of the sound from the medical device into the machine sound information at a same time as or immediately following the processing of the voice input into the user feedback information, and
wherein the user feedback information and the machine sound information are included together in a device status report that is transmitted to the remote system via the external network (Col. 9, line 52- Col. 10, line14, “At the same time as recording and/or transmitting the user feedback from the patient, the instant user feedback interface 450 may trigger the gathering of patient treatment and/or machine status information 460 from the dialysis machine 302 and/or any peripheral components connected thereto via the connection 301. This status information 460 may then be securely transmitted along with the user feedback information received from the patient 50 to the remote computer, server and/or location and thereby used to help understand the environment that caused the desire to provide user feedback. In one or more implementations, the status information 460 may include information about alarms on the dialysis machine 302, machine parameters, treatment details, status of supplies and/or other status information stored or available to the dialysis machine 302 at the time that the machine 302 is triggered via the user feedback interface 450 to provide the status information 460.”. After the patient pressed the feedback interface 450, the gateway device 310 records the verbal feedback of the patient and gathers the machine status information 460 at the same time. Then, the gateway device transmits the recorded feedback and the gathered machine status information to a remote server).
Yuds teaches the gateway device receives the machine status information (e.g., alarm information) from the dialysis medical machine via a wireless signal but fails to express teach the at least one microphone configured to receive sound from the medical device; and process the sound from the medical device into transmissible machine sound information.
However, in the same field of medical system, Albert teaches a sound detector 40 that is configured to receive and identify the sounds generated by one or more medical devices 12, 18, 26, 28, 30 and to transmit the identified sound information to a remote server. See Abstract, “A system for detecting medical audio alarms. The system includes a detector and a server. The detector further comprises a microphone that is configured to receive a sound of the alarm; a microcontroller configured to determine an alarm pattern from the sound and to compare the determined alarm pattern to a plurality of patterns stored in a memory to identify a cause of the alarm; and a network interface configured to transmit the cause of the alarm. The server is configured receive the cause of the alarm and provide notification of the cause of the alarm.”.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Yuds’s gateway device to receive and to identify sound outputted by the dialysis medical machine as taught by Albert to improve alarm sound identification.
Regarding claim 2, Yuds in the combination teaches the user feedback system of claim 1, wherein the medical device is a dialysis machine (Fig. 3, dialysis machine 302).
Regarding claim 3, Albert in the combination teaches the user feedback system of claim 1, wherein the sound from the medical device includes one or more of an alarm of the medical device or a mechanical sound from the medical device (Abstract and para [0032], the sound detector 40 is configured to receive and identify the alarm sounds generated by one or more medical devices 12, 18, 26, 28, 30).
Regarding claim 5, Albert in the combination teaches the user feedback system of claim 1, further comprising a detection device that is configured to detect the sound from the medical device (Fig. 2, detector 40), wherein the at least one microphone includes a microphone of the detection device (Fig. 4, microphone 46, 54, 58), and wherein, when the microphone of the detection device detects the sound from the medical device, the detection device records the sound (para [0009], “According to one embodiment of the present invention a system for detecting medical audio alarms includes a detector and a server. The detector further comprises a microphone that is configured to receive a sound of the alarm; a microcontroller configured to determine an alarm pattern from the sound and to compare the determined alarm pattern to a plurality of patterns stored in a memory to identify a cause of the alarm; and a network interface configured to transmit the cause of the alarm. The server is configured to receive the cause of the alarm and to provide notification of the cause of the alarm.”. The detector receives and stores the sound of the medical device.).
Regarding claim 6, Yuds in the combination teaches the user feedback system of claim 1, wherein the user feedback interface includes a button on a user feedback device that is remote from the gateway device and that communicates with the gateway device (Fig. 6, feedback device 650 that is remote from the gateway device 610).
Regarding claim 7, Yuds in the combination teaches the user feedback system of claim 1, wherein the user feedback interface includes two buttons that present two options to the user, wherein a first option of the two options is an identification option that indicates user identification information will be transmitted identifying the user, and wherein a second option of the two options is a non-identification option that indicates limited user identification information will be transmitted (Fig. 5, Fig. 6, Col. 10 line 15-24, “FIG. 5 is a schematic illustration showing another implementation of a user feedback system 500 that includes a gateway device 510, similar to the gateway device 410, but including another example of a user feedback interface 550 that includes multiple-option instant user feedback buttons 551, 552. Specifically, in the illustrated example, the buttons 551, 552 may include the following: a button for providing feedback with an ID (“ID” button 551), and a button for providing feedback anonymously, without explicit identification (“NO ID” button 552).”).
Regarding claim 8, Yuds in view of Albert teaches the user feedback system of claim 7, wherein, when the identification option is engaged, the user feedback information and the machine sound information transmitted by the gateway device to the remote system includes identifying information of the user and the medical device (Yuds, Col. 10 line 25-41, “For the feedback with ID option, e.g. after engaging the ID button 551, the patient 50 may provide voice feedback and information obtained in connection with the treatment for the patient 50. This information may include information provided by a fingerprint reader/patient card reader/keypad code entry/or electronic link of the dialysis machine 302 or gateway device 510 to the particular patient in the patient's medical record and may be securely transmitted along with the user feedback provided by the patient 50.” and Albert para [0032], “With reference still to FIG. 2, amplified sound received at the microcontroller 48 may be processed to determine a pattern of the alarm. FIG. 5 illustrates seven, exemplary and different alarms patterns that may be suitable for use with embodiments of the present invention. For example, pattern A may be associated with the IV pump 18 (FIG. 1), pattern B may be associated with low pulse ox level detection by the vital signs monitor 26 (FIG. 1), pattern C may be associated with a lower power detection of the IV pump 18 (FIG. 1), and so forth.”. Yuds in view of Albert teaches the modified gateway device is configured to identify the user and the medical machine via the alarm sound).
Regarding claim 9, Yuds in the combination teaches the user feedback system of claim 1, wherein, a responsive action in response to the user feedback information and the machine sound information is determined at the remote system, and wherein the user feedback system receives information about the responsive action from the remote system (Col. 14 line 13-20, “At a decision step 814, it is determined whether a responsive action is needed. The step 814 may include processing to determine if a responsive action is needed, such as whether there was an emergency health or machine status situation that needs resolving. The processing may also include processing the user feedback information to determine if a responsive customer service action is needed to respond to the user feedback.”. The server provides a responsive action for the user and for the machine information.).
Regarding claim 10, Yuds in the combination teaches the user feedback system of claim 1, further comprising a mobile computing device of the user that couples to the gateway device when brought into proximity to the gateway device and that is configured to provide an image or a video to the gateway device related to the voice input (Fig. 7, col. 3 line 7-11, “The system may further comprise a mobile computing device of the user that couples to the gateway device when brought into proximity to the gateway device and that is configured to provide an image or a video to the gateway device related to the voice input.”).
Regarding claim 11, recites a medical system that is similar to the system of claim 1. Therefore, the claim is rejected for the same reason.
Regarding claim 12, recites a medical system that is similar to the system of claim 2. Therefore, the claim is rejected for the same reason.
Regarding claim 13, recites a medical system that is similar to the system of claim 3. Therefore, the claim is rejected for the same reason.
Regarding claim 15, recites a medical system that is similar to the system of claim 5. Therefore, the claim is rejected for the same reason.
Regarding claim 16, recites a medical system that is similar to the system of claim 6. Therefore, it is rejected for the same reason.
Regarding claim 17, recites a medical system that is similar to the system of claim 7. Therefore, the claim is rejected for the same reason.
Regarding claim 18, recites a medical system that is similar to the system of claim 8. Therefore, the claim is rejected for the same reason.
Regarding claim 19, recites a medical system that is similar to the system of claim 9. Therefore, the claim is rejected for the same reason.
Regarding claim 20, recites a medical system that is similar to the system of claim 10. Therefore, the claim is rejected for the same reason.
Regarding claim 21, recites a method for the system of claim 1. Therefore, the claim is rejected for the same reason.
Regarding claim 22, recites a method for the system of claim 7. Therefore, the claim is rejected for the same reason.
Regarding claim 23, recites a method for the system of claim 8. Therefore, the claim is rejected for the same reason.
Regarding claim 24, recites a method for the system of claim 5. Therefore, the claim is rejected for the same reason.
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 ZHEN Y WU whose telephone number is (571)272-5711. The examiner can normally be reached Monday-Friday, 10AM-6PM, EST.
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/ZHEN Y WU/Primary Examiner, Art Unit 2685
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