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 .
Information Disclosure Statement
The Information Disclosure Statement filed 11/11/2025 has been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see pages 8-11, filed 11/11/2025, with respect to the 35 U.S.C. 102 rejection of claim 1 have been fully considered but they are not persuasive. The Applicant argues that the features of FIG. 2 and Pars. [0028] and [0050] of Li, et al. (U.S. PGPub No. 2018/0020977) relied upon in rejecting claim 1 are unsupported by Li’s Provisional Application (PRO 62/117,679 – i.e., the ‘679 provisional application). The Applicant further argues that the ‘679 provisional application fails to disclose or suggest a cardiac monitoring system with a mobile computing device with “memory storing instructions executable by the mobile computing device processor to … send a message to a predetermined recipient responsive to the physiological diagnosis indicating a cardiac abnormality” as recited in claim 1. The Applicant argues that for at least this reason, independent claim 1 is patentable over Li as cited, and that 35 U.S.C. 102(a)(2) rejection of independent claim 1 should be withdrawn.
This is not found persuasive. The Examiner maintains that the 35 U.S.C. 102(a)(2) rejection over Li was proper, and that Li’s ‘679 provisional application has support for teaching the indicated limitation. It is noted that Li’s ‘679 provisional application contains two specification documents, both filed on 02/18/2015. One of the specification documents is two pages and the other specification document is eleven pages. The Examiner maintains that the cited portions of Li relied upon for teaching the limitation “memory storing instructions executable by the mobile computing device processor to … send a message to a predetermined recipient responsive to the physiological diagnosis indicating a cardiac abnormality” have support in the specification documents of Li’s ‘679 provisional application. The Examiner also maintains that Li’s ‘679 provisional application teaches the indicated limitation. Towards the end of the introduction of the two-page specification in Li’s ‘679 provisional application, Li explains that “Using a smartphone to communicate with these wearable devices is convenient, because people carry smartphone around and the smartphone has the ability to further analyze the data, to transfer the data to the physicians, and/or to upload the data to a database”. Li also explains that “We will use BLE to transfer the data to smartphone or laptop for further analysis of data”. At the beginning of the introduction of the two-page specification in Li’s ‘679 provisional application, Li explains that “Among those symptoms, detection and early warning of the potential of heart attack such as myocardial infarction can be crucial in daily life for patients, especially those who live alone, because once happened, it need to be taken immediate care of”. Based on at least these combined teachings, Li’s ‘679 provisional application is found to have support for Li’s non-provisional application and to teach the indication limitation “memory storing instructions executable by the mobile computing device processor to … send a message to a predetermined recipient responsive to the physiological diagnosis indicating a cardiac abnormality”. In this case, physicians would be considered the predetermined recipient. Therefore, Applicant’s arguments are not found persuasive, and the 35 U.S.C. 102 rejections of claims 1-6 are maintained. Please see 35 U.S.C. 102 rejections of claims 1-6 hereinbelow.
Applicant’s arguments with respect to claim 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In particular, Justice, et al. (U.S. PGPub No. 2015/0342522) is now relied upon to address the added claim limitation “comprising a plurality of spaced-apart bumps”. Please see 35 U.S.C. 103 rejection of claim 7 in view of Li, et al. and Justice, et al. With regards to Applicant’s argument regarding the added claim limitation “the frame having a continuous annular structure”, it is noted that this argument is not found persuasive and that Li is found to teach this limitation. The disclosure in Li’s ‘679 provisional application regarding the fabricated device being rolled into a ring format does not preclude the frame from having a continuous annular structure. The Examiner notes that the frame would be considered a continuous annular structure once it is rolled into a ring format. It is also noted that on page 5 of the eleven page specification document in Li’s ‘679 provisional application, the frame appears to be in a continuous annular structure. It is also noted that Li’s naming of a “ring” format also supports the notion that the ring becomes a continuous annular structure once it is rolled up. Dictionary.com defines “ring” as “a circular or surrounding line or mark”. This definition corresponds to a “continuous annular structure”. Therefore, Li’s ‘679 provisional application is found to teach the limitation “the frame having a continuous annular structure”. Please see 35 U.S.C. 103 rejections below.
Applicant’s arguments, see pages 15-17, filed 11/11/2025, with respect to the prior art rejection of dependent claim 10 have been fully considered but they are not persuasive. The Applicant points to Pars. [0044] and [0046] of Li and argues that Li discloses an embodiment that includes a third electrode that functions as a driven electrode to reduce common-mode interference. The Applicant argues that common-mode interference can result from an imbalance between the contact resistances associated with two electrodes, and a driven electrode can improve the signal-to-noise ratio of a signal measured by two other electrodes for reducing common-mode interference. The Applicant argues that because Li discloses a wearable band with a third electrode only in the context of providing a driven electrode for improving the signal-to-noise ratio associated with two other electrodes, Li fails to disclose or suggest a wearable band with a third electrode “adapted to detect a third cardiovascular signal from an EKG lead location on the person’s body apart from the finger and the second body part” as recited in claim 10.
This is not found persuasive. Li does not disclose that the third electrode must be or can only be a driven electrode, as the Applicant alleges. For instance, please see Fig. 3(a) and Fig. 3(b) that shows Electrode 1 (252) and Electrode 2 (254) both on the outside of the ring and neither being denoted as “driven electrodes”. Li explains that a first electrode 252 can be located at a first side (i.e., at the outer surface or outer side when in the shape of the ring) of the substrate 102, and a second electrode 254 can be located at that same first side of the substrate 102, but offset to one side (Par. [0043]). Li further teaches that one or both electrodes 252, 254 can be pressed against the body of the patient (Par. [0043]). Li also teaches that the electrodes 252, 254 are able to obtain a reliable signal from the body (Par. [0035]). Li’s teaching of the additional electrodes as driven electrodes is an option and not the only option. For instance, Li teaches that the additional electrodes can be driven electrodes (Par. [0044]). Additionally, Li teaches that such optional driven electrodes are separate from the first and second electrodes 252,254 (Par. [0044]). The Examiner notes that Li’s teaching of “three electrodes setup for better signal to noise ratio” is not directly tied to Li’s teaching of using optional driven electrodes (Par. [0046]). Using a third electrode for detecting a third cardiovascular signal would also cause a better signal to noise ratio. Therefore, it is maintained that Li teaches the indicated limitation of claim 10. Please see prior art rejections below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Li, et al. (U.S. PGPub No. 2018/0020977).
Regarding claim 1, Li teaches (Fig. 2, # 10) a cardiac monitoring system (Par. [0010] – wearable ECG monitoring system is provided; Par. [0024]) comprising:
(Figs. 2-3, # 100 – ring sensor) a wearable band configured to be worn around a finger of a person (Par. [0010] – a wearable ECG monitoring system is provided that is capable of providing on-demand multiple-lead ECG signals in the format of a flexible finger ring; Par. [0024]; Par. [0040]; Par. [0043]); and
(Fig. 2, # 300 – mobile device) a mobile computing device paired with the wearable band via wireless communication (Par. [0024] – the ring sensor 100 and the patient device 300 can each have a wireless module and associated software so that the ring sensor 100 can wirelessly communicate with the patient device; Par. [0077] – the sensor 100 is used in connection with a patient mobile device 300),
wherein the wearable band comprises:
(Fig. 3c-d, # 254 – second electrode, i.e. first electrode) a first electrode adapted to detect a first cardiovascular signal from the finger (Par. [0026]; Par. [0043] – second electrode 254 is pressed against the patient’s finger and can take a measurement from the patient’s finger);
(Figs. 3c-d, # 252 – first electrode, i.e. second electrode) a second electrode adapted to detect a second cardiovascular signal from a second body part of the person, on which the wearable band is not worn, when the second body part is touched against the second electrode (Par. [0026] – -the electrode on the outside of the ring is touched to the opposite hand or other parts of the body other than the wearing limb in order to obtain multi-lead ECG signals; Par. [0043] – first electrode 252 can be located at the outer surface of the ring and pressed to one part of the body);
(Fig. 2, # 120 – microcontroller system, i.e. wearable band processor, 200 – Analog Front End System) a wearable band processor adapted to generate a measured data set that represents one or more measured physiological properties of the person based, at least in part, on one or both of the first cardiovascular signal and the second cardiovascular signal (Par. [0030-0032] – the microcontroller system 120 controls the operation of the whole system, including data acquisition. The use can initiate a measurement to be taken and save it in the on-chip flash memory; Par. [0034-0035] – commercial ECG analog front end (AFE) chip can be used for the ECG signal acquiring and conditioning); and
(Fig. 2, # 100, 300) a wearable band wireless communications device adapted to transmit the measured data set to the mobile computing device (Par. [0038] – the ring 100 can have a wireless communication subsystem that is connected to or integrated with the MCU 120. The wireless communication subsystem can be BLE which allows for communications or data exchange between the ring 100 and the smartphone 300),
wherein the mobile computing device comprises:
(Fig. 2, # 300) a mobile computing device processor (Par. [0050] – smartphone’s functions are representative of the smartphone necessarily having a processor);
(Fig. 2, # 300) a mobile computing device wireless communications device adapted to receive the measured data set from the wearable band (Par. [0024] – the ring sensor 100 and the patient device 300 can each have a wireless module and associated software so that the ring sensor 100 can wirelessly communicate with the patient device 300; Par. [0030] – the user can pair the ring with a smartphone 300 to upload previous measurement; Par. [0037]); and
memory storing instructions executable by the mobile computing device processor to:
(Fig. 2, # 300) produce a physiological diagnosis that is based, at least in part, on the measured data set by one or both of:
analyzing the measured data set to generate the physiological diagnosis; and
transmitting the measured data set to a cloud based server that generates the physiological diagnosis and receiving the physiological diagnosis from the cloud based server (Par. [0050] – the UI device can be a smartphone with a custom application and can be used to conduct some more sophisticated analysis. The measured data can be uploaded to the cloud. If the app finds any irregularity during the analysis, the patient device 300 can send data to user’s physician for further analysis. A diagnosis algorithm can be on the UI device); and
(Fig. 2) send a message to a predetermined recipient responsive to the physiological diagnosis indicating a cardiac abnormality (Par. [0028]; Par. [0050] – If the app finds any irregularity during the analysis, the patient device 300 can send data (e.g., by email or phone call) to user’s physician for further analysis. The emergency response organization can be contacted immediately as well.).
Therefore, claim 1 is unpatentable over Li, et al.
Regarding claim 2, Li teaches the cardiac monitoring system of claim 1, wherein (Fig. 2) the predetermined recipient comprises one or more of a designated healthcare provider, a designated emergency services provider, a designated personal contact, and a designated emergency contact (Par. [0028] and [0050]).
Therefore, claim 2 is unpatentable over Li, et al.
Regarding claim 3, Li teaches the cardiac monitoring system of claim 1, wherein the memory stores instructions executable by the mobile computing device processor to send the message to the predetermined recipient via one or both of a text message and a phone notification (Par. [0028] and [0050]).
Therefore, claim 3 is unpatentable over Li, et al.
Regarding claim 4, Li teaches the cardiac monitoring system of claim 1, wherein (Fig. 2, # 10 – ECG system, 120, 200, 252, 254) the one or more measured physiological properties comprise an EKG signal detected by one or both of the first electrode and the second electrode, wherein the measured data set comprises an EKG data set that is based, at least in part, on the EKG signal (Title, Abstract; Par. [0024]; Par. [0026] – first and second electrodes used to obtain multi-lead ECG signals; Par. [0030] and [0035]), wherein (Fig. 2, # 300) the memory stores instructions executable by the mobile computing device processor to assess the EKG data to determine if the EKG data is abnormal and to send the message responsive to determining that the EKG data is abnormal (Par. [0028]; Par. [0050] – the UI device can be a smartphone with a custom application and can be used to conduct some more sophisticated analysis. The measured data can be uploaded to the cloud. If the app finds any irregularity during the analysis, the patient device 300 can send data (e.g., by email or phone call) to user’s physician for further analysis. The emergency response organization can be contacted immediately as well. A diagnosis algorithm can be on the UI device).
Therefore, claim 4 is unpatentable over Li, et al.
Regarding claim 5, Li teaches the cardiac monitoring system of claim 1, wherein (Fig. 2, # 252, 254) the wearable band further comprises one or more physiological sensors, each configured to detect a respective physiological signal from the finger, wherein the one or more measured physiological properties are based, at least in part, on the respective physiological signal detected by at least one of the one or more physiological sensors, and wherein the one or more physiological sensors comprise one or more of a heart rate sensor, a pulse oximetry sensor, a galvanic skin sensor, and a multi- axis accelerometer (Title, Abstract, Par. [0026] – electrodes used to obtain multi-lead ECG signals; Par. [0028]; Par. [0073] – pulse oximeter).
Therefore, claim 5 is unpatentable over Li, et al.
Regarding claim 6, Li teaches the cardiac monitoring system of claim 5, wherein the one or more measured physiological properties comprise:
a heart rate of the person (Title, Abstract, Par. [0003] – ECG is considered a heart rate sensor; Par. [0026]); and
one or more contextual metrics measured by the one or more physiological sensors, wherein the one or more contextual metrics comprise one or more of a measured blood oxygen level, a measured motion of the person, and a measured acceleration of the person (Par. [0073] – pulse oximeter determines a measured blood oxygen), and
wherein the memory stores instructions executable by the mobile computing device processor to send the message responsive to the physiological diagnosis indicating an abnormal correspondence between the heart rate and the one or more contextual metrics (Par. [0028]; Par. [0050]; Par. [0073] – the measurement of ECG can be used with other vital signs to get more information about personal health. The ECG signal combined with pulse oximetry, where the pulse oximeter can be integrated onto the ring.).
Therefore, claim 6 is unpatentable over Li, et al.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Li, et al. (U.S. PGPub No. 2018/0020977) in view of Justice, et al. (U.S. PGPub No. 2015/0342522).
Regarding claim 7, Li teaches (Figs. 2-3, # 100 – ring sensor) a wearable band (Par. [0010]) comprising:
(Figs. 2-3, # 100 – ring sensor, 102 – ring, i.e. continuous annular structure when connector 104 locked) a frame configured to be worn around a finger of a person, the frame having a continuous annular structure, an inner surface that faces the finger and an outer surface that faces away from the finger (Par. [0010] – a wearable ECG monitoring system is provided that is capable of providing on-demand multiple-lead ECG signals in the format of a flexible finger ring; Par. [0024]; Par. [0026] – one electrode inside the ring and another electrode outside the ring to touch another part of the user’s body; Par. [0040-0041] – when the connector is locked, the sensor 100 has a ring shape; Par. [0043]; Page 3 and 5 of Li’s ‘679 provisional application – the frame has a continuous annular structure once it is in the “rolled into a ring” format.);
(Fig. 3c-d, # 254 – second electrode, i.e. first electrode) a first electrode on the inner surface of the frame, the first electrode adapted to detect a first cardiovascular signal from the finger (Par. [0026]; Par. [0043] – second electrode 254 is pressed against the patient’s finger and can take a measurement from the patient’s finger);
(Figs. 3c-d, # 252 – first electrode, i.e. second electrode) a second electrode on the outer surface of the frame, the second electrode adapted to detect a second cardiovascular signal from a second body part of the person, on which the wearable band is not worn, when the second body part is touched against the second electrode (Par. [0026] – -the electrode on the outside of the ring is touched to the opposite hand or other parts of the body other than the wearing limb in order to obtain multi-lead ECG signals; Par. [0043] – first electrode 252 can be located at the outer surface of the ring and pressed to one part of the body);
(Fig. 2, # 120 – microcontroller system, i.e. wearable band processor) a processor Par. [0030-0032] – the microcontroller system 120 controls the operation of the whole system, including data acquisition. The use can initiate a measurement to be taken and save it in the on-chip flash memory);
(Fig. 2, # 100, 300) a wireless communications device (Par. [0038] – the ring 100 can have a wireless communication subsystem that is connected to or integrated with the MCU 120. The wireless communication subsystem can be BLE which allows for communications or data exchange between the ring 100 and the smartphone 300); and
memory storing instructions executable by the processor to:
(Fig. 2, # 120 – microcontroller system, i.e. wearable band processor, 200 – Analog Front End System) record one or more measured physiological properties of the person based, at least in part, on one or both of the first cardiovascular signal and the second cardiovascular signal;
generate a measured data set based, at least in part, on the one or more measured physiological properties (Par. [0030-0032] – the microcontroller system 120 controls the operation of the whole system, including data acquisition. The use can initiate a measurement to be taken and save it in the on-chip flash memory; Par. [0034-0035] – commercial ECG analog front end (AFE) chip can be used for the ECG signal acquiring and conditioning); and
(Fig. 2, # 100, 300) transmit the measured data set to a mobile computing device via the wireless communications device (Par. [0024] – the ring sensor 100 and the patient device 300 can each have a wireless module and associated software so that the ring sensor 100 can wirelessly communicate with the patient device 300; Par. [0030] – the user can pair the ring with a smartphone 300 to upload previous measurement; Par. [0038] – the ring 100 can have a wireless communication subsystem that is connected to or integrated with the MCU 120. The wireless communication subsystem can be BLE which allows for communications or data exchange between the ring 100 and the smartphone 300). Li does not explicitly teach the limitation of instant claim 7, that is wherein the first electrode is comprising a plurality of spaced-apart bumps.
Justice is directed to analogous art, and teaches a sensory-and-logic system that includes a ring-shaped, electrically-conductive skin sensor sized and shaped to form an electrical connection with human skin (Title, Abstract). Justice also teaches the limitation of instant claim 7, that is wherein (Fig. 1A, # 44A; Fig. 2, # 202) the first electrode is comprising a plurality of spaced-apart bumps (Par. [0022] – First contact sensor module 44A includes a first ring-shaped, electrically conductive skin sensor 202, sized and shaped to contact human skin, surrounding optical pulse rate sensor 46; Par. [0023] – First skin sensor 202 comprises an electrode. Further, in some examples, the outward surface of first skin sensor 202 may include a plurality of protrusions (i.e., bumps) and/or a rough finish in order to promote contact with a wearer’s skin; Par. [0027]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the protrusions (i.e., bumps) on the electrodes used in Justice’s wearable biometric monitoring device into the electrodes of Li’s device, because doing so would be an example of using a known technique to improve similar devices in the same way. One of ordinary skill in the art would have desired protrusions on the electrode/skin sensor in order to promote contact with a wearer’s skin (see at least Par. [0023] of Justice).
Therefore, claim 7 is unpatentable over Li, et al. and Justice, et al.
Regarding claim 8, Li, in view of Justice, renders obvious the wearable band of claim 7, as indicated hereinabove. Li also teaches the limitation of instant claim 8, that is wherein (Fig. 2, # 10 – ECG system, 120, 200, 252, 254) the one or more measured physiological properties comprise an EKG signal detected by one or both of the first electrode and the second electrode, and wherein the measured data set comprises an EKG data set (Title, Abstract; Par. [0024]; Par. [0026] – first and second electrodes used to obtain multi-lead ECG signals; Par. [0030] and [0035]).
Therefore, claim 8 is unpatentable over Li, et al. and Justice, et al.
Regarding claim 9, Li, in view of Justice, renders obvious the wearable band of claim 7, as indicated hereinabove. Li also teaches the limitation of instant claim 9, that is wherein the wearable band is further comprising (Fig. 2, # 252, 254) one or more physiological sensors, each configured to detect a respective physiological signal from the finger, wherein the one or more measured physiological properties are based, at least in part, on the respective physiological signal detected by at least one of the one or more physiological sensors, and wherein the one or more physiological sensors comprise one or more of a heart rate sensor, a pulse oximetry sensor, a galvanic skin sensor, and a multi-axis accelerometer (Title, Abstract, Par. [0026] – electrodes used to obtain multi-lead ECG signals; Par. [0028]; Par. [0073] – pulse oximeter).
Therefore, claim 9 is unpatentable over Li, et al. and Justice, et al.
Regarding claim 10, Li, in view of Justice, renders obvious the wearable band of claim 7, as indicated hereinabove. Li also teaches the limitation of instant claim 10, that is wherein the wearable band is further comprising (Figs. 3a-d) a third electrode on the outer surface of the frame, generally opposite from the second electrode, the third electrode adapted to detect a third cardiovascular signal from an EKG lead location on the person's body apart from the finger and the second body part (Par. [0035]; Pars. [0042-0046] – the ring can have two or more electrodes (i.e., third electrode)… additional electrodes can be optionally provided at the first side and/or a second opposite side… one electrode should always be on the outside surface of the ring, and the other electrodes can be either on the outside surface or the inside surface).
Therefore, claim 10 is unpatentable over Li, et al. and Justice, et al.
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 MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796