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: The current application has the effective filing date of 06/04/2021 according to the priority chain on the record.
Response to Amendment
Regarding the claim objection, these are withdrawn in view of the current claim amendment.
Then 35 USC 112(f) interpretations are maintained.
The 35 USC 101 rejection to the pending claims 1-17 are withdrawn in view of the current claim amendment.
As for the 35 USC 112 rejection, these rejections are withdrawn.
As for the 35 USC 102 and 103 rejections based on Haller et al. US 7,149,773, the Applicant’s arguments have been fully considered but are not entirely persuasive.
Independent claims 1 and 12 have been amended to include the PR (patient’s remote device) performing ‘validity check’ feature. Haller, in Figs. 12B and 12C (and col.43, ll.44- col.44, ll.46) illustrates the server 130, at least, checking whether software/firmware application (to be transmitted/uploaded to the IMD 10) complies with regulatory requirements associated with the IMD. Haller’s approval with respect to government and regulatory requirements is taken to encompass “predefined structural format” in the claim. Haller does not teach the patient device (100/110) performing said validity check feature, but this is taught in Drew US 2013/0283030 A1, please see new grounds of rejections below.
New grounds for double patenting rejection is made below in view of the current claim amendment.
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 1-6 and 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-11 of U.S. Patent No. 11,694,779 (Pat’779). Although the claims at issue are not identical, they are not patentably distinct from each other because the current application discloses an invention that is patentably substantially the same as pat’779, as shown in the italicized limitations below:
App. 18/561472
US Pat. 11,694,779 (Pat’779)
Claim 1: A system comprising at least one a medical device (7), a remote monitoring server (RMS, 1) and at least one patient remote device (PR, 5), wherein the PR is configured to establish a first bidirectional communication connection (12, 14) of the PR and the RMS and a second bidirectional communication connection (13, 14) of the PR and one chosen the medical device, wherein the PR is further configured to manage remote processes associated with the chosen medical device comprising remote interrogation of the chosen medical device and remote programming of the chosen medical device using the second bidirectional communication connection as well as data exchange with the RMS concerning one or both of:(i) interrogation data, or (ii) program data with regard to the chosen medical device using the first bidirectional communication connection; and
wherein the PR is configured to perform a validity check on program data received from the RMS to determine if the program data complies with a predefined structural format before transmitting the program data to the medical device
Claim 1: A system comprising at least one medical device (7), a remote monitoring server (RMS, 1) and at least one patient remote device (PR, 5), wherein the PR is configured to establish a first bidirectional communication connection (12, 14) of the PR and the RMS and a second bidirectional communication connection (13, 14) of the PR and one chosen medical device, wherein the PR is further configured to manage remote processes associated with the chosen medical device comprising remote interrogation of the chosen medical device and remote programming of the chosen medical device using the second bidirectional communication connection as well as data exchange with the RMS concerning interrogation data and/or program data with regard to the chosen medical device using the first bidirectional communication connection; wherein the management of remote processes in the at least one PR (5) comprises a validity check on a program for remote programming of the medical device (7).
As shown above, claim 1 is rejected by claim 1 of Pat’779 for reciting substantially the same matter. The only difference is using “one or both” to “and/or”, but these phrases are not patentably distinct from one another.
Claim 2 is rejected by claim 2 of Pat’779 for reciting substantially the same matter.
Claim 3 is rejected by claim 3 of Pat’779 for reciting substantially the same matter.
Claim 4 is rejected by claim 4 of Pat’779 for reciting substantially the same matter.
Claim 5 is rejected by claim 5 of Pat’779 for reciting substantially the same matter.
Claim 6 is rejected by claim 6 of Pat’779 for reciting substantially the same matter.
Claim 8 is rejected by claim 8 of Pat’779 for reciting substantially the same matter.
Claim 9 is rejected by claim 9 of Pat’779 for reciting substantially the same matter.
Claim 10 is rejected by claim 10 of Pat’779 for reciting substantially the same matter.
Claim 11 is rejected by claim 11 of Pat’779 for reciting substantially the same matter.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Medical device
Patient remote device
Remote monitoring server
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Haller et al. US 7,149,773 B2 (hereinafter “Haller”, previously cited) and in view of Drew US 2013/0283030 A1.
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Regarding claim 1, Haller teaches system (Figs. 6B-6C) comprising at least one medical device (7) (IMD 10), a remote monitoring server (RMS, 1) (remote computer system 120) and at least one patient remote device (PR, 5) (communication module 100/mobile telephone or PDA 110), wherein the PR is configured to establish a first bidirectional communication connection (12, 14) of the PR and the RMS (see Fig. 6C; and col.7, ll.21-col.8, ll.45 two way communication between 100/110 and 120) and a second bidirectional communication connection (13, 14) of the PR and medical device (see Fig. 6C, and col.7, ll.21-col.8, ll.45 two way communication between 100/110 and 10), wherein the PR is further configured to manage remote processes associated with the medical device comprising remote interrogation of the medical device and remote programming of the medical device using the second bidirectional communication connection (col.8, ll.6-25 see (j)-(l), 100/110 is capable of relaying real-time programming/feedback information from the server 120 to the IMD 10, and capable of receiving physiological data and device interrogation/performance data to then relay back to the server 120) as well as data exchange with the RMS (130) concerning one or both of:
interrogation data (col.19, ll.65, col.20, ll.1 “IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110.”), or
program data with regard to the chosen medical device using the first bidirectional communication connection. (col.38, ll.21-28 “IMD 10 and/or communication module 100/mobile telephone or PDA 110, contact a physician or specialist indicated in a database of remote system 130 as being patient 5's emergency contact to request that the physician or specialist review data or reports provided by the system of the present invention and subsequently adjust the operating parameters of IMD 10. Or IMD 10 may be re-programmed with new software or algorithms in response to review and analysis of information obtained remotely from IMD 10.”).
Haller further discloses wherein the RMS is configured to perform a validity check on program data received to determine if the program data complies with a predefined structural format before transmitting the program data to the medical device. (See Figs. 12B and 12C and col.43, ll.44- col.44, ll.46; the server 130, at least, checking whether software/firmware application (to be transmitted/uploaded to the IMD 10) complies with regulatory requirements associated with the IMD. Haller’s approval with respect to government and regulatory requirements as discussed here is taken to encompass “predefined structural format” in the claim). The approved software/firmware programs are then transmitted form the RMS, to the PR, and finally installed at the implantable medical device. Although Haller does not teach wherein the validity check is performed at the PR, it would have been an obvious design choice for a person to do so at the time of invention, because it is common practice to distribute processing functionalities amongst various computing components within a telemetry system, and Haller has certainly demonstrated that the PR has communications properties and computing capabilities to performed the discussed validity checks prior to updating the programming in the IMD, see Haller col.28, ll,.47-55 and col.38, ll.46-col.38, ll.11.
Alternatively, Drew, a prior art reference in the analogous art of reprogramming an implantable medical device by an external programmer (see Abstract). Drew, Figs. 3-4 illustrates a communication process between an IMD and external programmer (interpreted as “PR” in this claim), wherein the external programmer has processing feature of creating restoration points, validating and/or invalidating therapy configurations that are compatible with the IMD, see [0073, 0075, 0077, 0094-0100]. It would have been obvious to modify Haller in view of Drew, such that the validity checks taught in Haller’s RMS is performed in the PR, because Drew has shown that that an external programmer can be configured to have the communication and processing capability to carry application validity checks.
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Regarding claim 2, Haller further teaches the system of claim 1, wherein the system further comprises at least one health care professional(HCP) remote device (CP, 3) (Fig. 6B: remote computer system 131 and/or 131'), wherein the at least one CP is configured to establish a third bidirectional communication connection (11, 14) (Fig. 6B: 137’ and 137’’) of the at least one CP (131, 131’) and the RMS (1) (130) in order to provide one or both of:
(i) additional real-time remote programming (col.19, ll.35-53 physicians 135/136 utilizes the CP, i.e. 131’/131’’ for real-time remote communication with patient’s device 110 or IMD 10; also see col.36, ll.1-7 “emote system 130 or remote health care provider 136 initiates communication for patient monitoring, clinical study monitoring, therapeutic, clinical outcome study or other purposes to thereby minimize unnecessary patient-physician or patient-hospital interaction.”), or
(ii) interrogation of the medical device using the at least one CP via the RMS and one PR (5) corresponding to the medical device. (col.19, ll.35-53, and col.36, ll.61-col.37, ll.6 physician can be 131’/131’’ to interrogate the patient’s device 100 or IMD 10 for sensor data)
Regarding claim 3, Haller further teaches the system of claim 1, wherein the system is configured to maintain one or more of: (i) the first communication connection, (ii) the second communication connection, or (iii) the third communication connection as a continuous communicationsee Figs. 6B and 6C; and col.8, ll.21-27 “…(m) use of a highly flexible and adaptable communications scheme to promote continuous and preferably real-time data communications between a remote expert data center, remote computer, and/or remote health care provider or health care provider and the communication module via a mobile telephone…”)
Regarding claim 4, Haller modified teaches the system of claim 3, Haller and Drew do not explicitly teach wherein the system is configured such that the continuous communication connections are maintained until a close signal is sent from one or both of: (i) the one CP (3) to the chosen medical device via the RMS (1) and the corresponding PR (5), or (ii) one PR to the connected medical device and the RMS. However, Haller teaches the communications network utilizes telephone/internet communications network (col.18, ll.46-58, col.19, ll16-21), and that the server 130 can transmit remedial action to control/change the operations of the patient’s device 100 and IMD 10 (col.33, ll.16-25, col.40, ll.2-5). Further, it is common knowledge that a PDA or cellphone 100/100, and a computer server 130 can disconnect from a known telephone/internet communications network. As such, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Haller such that the RMS (server 130) can transmit a close signal to the PR (patient device 100/110), the motivation for doing so is such that a server would be able to disconnect from the patient devices in case of data corruption, and/or to end patient care.
Regarding claim 5, Haller further teaches the system of claim 1, wherein the at least one PR (5) is a smartphone. (100/110 is a PDA or mobile phone, this is sufficient to encompass “smartphone” recited in this claim based on the functionality of 100/110 discussed in col.30, ll. 7-col.31, ll.43, including communication, visual and audio input/output, processing and interactive capabilities)
Regarding claim 6, Haller further teaches the system of claim 1, wherein the at least one PR (5) (PDA 100/110) is configured to monitor and control incoming and outgoing communication data with regard to the second bidirectional communication connection. (As shown in Fig.6C, PDA 100/110 controls the uplink, i.e. “relay or store and relay”, and downlink, i.e. “reception of action & advice”; also see col.25, ll.34-40)
Regarding claim 7, Haller teaches the system of claim 2, wherein the at least one PR (5) (100/110) provides a user interface platform (col.22, ll.1-22, col.31, ll.4-17 PDA 100/110 has a under interface 108, this is taken to encompass “user interface platform”) configured to one or more of:
i) intervene in the management of remote processes in the at least one PR by the patient,
(ii) intervene in management of remote processes in the at least one PR by the HCP,
(iii) control the management of remote processes in the at least one PR by the patient, or
(iv) control the management of remote processes in the at least one PR by the HCP. (col.35, ll.,41-col.36, ll.15, col.39, ll.51-84, col.41, ll.43-47 PDA 100/110 has a display and keyboard that allows a user to receive and input information, including health monitoring, e.g. receive alerts, and for communicating with physician/call ambulance etc.; these are taken to encompass limitations (i) to (iv) as recited in this claim. Alternatively, see Figs. 9A-9C, patient device 100/110 initiates communication with either server 130, or HCP 131’)
Regarding claim 8, Haller further teaches the system of claim 1, wherein the management of remote processes in the at least one PR (5) (100/110) comprises a validity check on a program for remote programming of the medical device (7) (10). (col.8, ll.35-44 data integrity checks; col.8, ll.56-59 debugging data, as shown in Fig. 12B-12C)
Regarding claim 9, Haller further teaches the system of claim 1, wherein the at least one PR (5) (100/110) is configured to support one or both of video call functionality or audio call functionality simultaneously with displaying interrogation data of the medical device (7). (see col.43, ll.7-21 voice and video communications, and col.38, ll.19-38 interrogating data)
Regarding claim 10, Haller further teaches the system of claim 1, wherein, prior to or during establishing the second communication connection between the RMS (1) (130) and the corresponding PR (5) (100/110), the RMS is configured to send a push notification to the corresponding PR thereby triggering this PR to poll the RMS at a faster rate. (col.7, ll.36-40, col.22, ll.23-39 handshake protocol, and setting communication frequency as continuous, relative continuous or intermittent; see col.30, ll.49-54)
Regarding claims 12 and 13, these claims are rejected by Haller in view of Drew under the same rationale as discussed to claims 1 and 2 above.
Regarding claim 14, Haller teaches a computer program product comprising instructions which, when executed by at least one processing unit of the PR, cause the at least one processing unit to perform the steps of the method according to claim 12. (see Col.9, ll.8-24 software for maintaining the communication module is remotely maintained. Alternatively, as shown in Figs. 6B-6C, the communication’s method is carried out by computer-based devices which individually include a processing unit; as such it is sufficient to encompass “computer program product” recited in this claim)
Regarding claim 15, Haller further teaches computer readable data carrier storing a computer program product according to claim 14. (See rejection to claim 14 above.)
Regarding claim 16, Haller further teaches the system of claim 2, wherein the at least one PR (5) (100/110) is configured to provide one or more of: (i) patient surveys (col.35, ll.42-53 displaying messages and question to a patient), (ii) patient information push to the HCP (Figs. 9A-9C, col.38, ll.63-67, col.39, ll.19-28, patient information push to the provider based on schedule or detected event), or (iii) patient appointment requests. (col.6, ll.48-51, col.21, ll.58, col.40, ll. 11-21 patient using PDA 100 to contact health care provider/physician)
Regarding claim 17, Haller further teaches the system of claim 1, wherein the at least one PR (5) (100/110) is configured to one or both of: (i) restrict pre-defined built-in functionality of the at least one PR, or (ii) prohibit pre-defined built-in functionality of the at least one PR. (col.37, ll.51-53 “…IMD functionalities or features can be enabled or disabled in IMD 10.”; col.44, ll.29-34 disable or defer updates or changes to operation)
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Haller and Drew as applied to claim 1 above, and further in view of Kumar US 2017/0120062 A1.
Regarding claim 11, Haller modified teaches the system of claim 1, wherein for remote programming of the chosen medical device the CP (3) (131’/131’’) is configured to produce a single program (this is interpreted as treatment regimen/program) containing the one or both of updates or changes of the medical device's parameters and to transmit the single program to the medical device via the RMS (1) (130) and the corresponding PR, wherein the RMS is configured to encrypt the single program received from the CP (131’/131’’) (col.34, ll.34-51, col.38, ll.16-35, col.45, ll.49-60, col.46, ll.51-col.47, ll.5, a physician can send entire prescribed treatment protocol or updates/changes to previously prescribed treatment protocol via the server 130 to the patient’s device 100/110 and IMD 10; these are taken to encompass both “updates or changes” as recited in this claim). Haller does not disclose wherein the corresponding PR (5) (100/110) is configured to transmit the encrypted single program to the chosen medical device (10).
Kumar, another prior art reference in the analogous art of remote programming and monitoring of an implantable device over a communications network (see Figs.1-2), discloses a system comprising a PR (204), RMS (210), medical device (150) and CP (208), and wherein the communication of data between these various components are encrypted so as to comply with data security requirements ([0051-0052]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Haller so as to encrypt all data transmission between devices in view of Kumar, this is necessary in order to comply with medical data security requirements, i.e. HIPAA.
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 SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
February 27, 2026