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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: page 390 and 391 lists element S107150 (it is noted the specification amendment filed 12/4/2025 does not renumber this element consistent with the drawing amendment) . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant's arguments filed 12/4/2025 have been fully considered but they are not persuasive. In response to applicant's argument that Hoegnelid fails to disclose a pressure senor configured to acquire sensor data indicative of a pressure in a hydraulic system implant, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Hoegnelid discloses the present invention includes pump devices (e.g. Column 1, lines 50-55) and Column 3, lines 7-11 discloses pressure sensitive element for sensing parameters in the body.
In order to advance prosecution, Forsell (US Publication 2015/0374906) discloses an implant comprising a pressure sensor in connection with at least one of a pump and a reservoir for determining a pressure in the reservoir and from the hydraulic pump (e.g. Paragraphs [0028], and [0832]) which would provide the predictable results of identifying the pressure in the reservoir or the hydraulic pump to identify changes that would potentially change the therapeutic effect of the device.
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.
Claims 44, 45 and 54 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 44, and 45 recite the limitation "the sensor”. There is insufficient antecedent basis for this limitation in the claim. The examiner assumes this should be “the pressure sensor” for consistency.
Claim 54 states “the sensor measurement”. There is insufficient antecedent basis for this limitation in the claim. The examiner assumes this should be “the sensor data” for consistency
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 43-45, 51, and 57-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoegnelid et al (US Patent 5,350,412) in view of Forsell (US Publication 2015/0374906).
Referring to Claim 43, Hoegnelid et al teaches an implant for implanting in a patient, comprising: a controller connected to or comprised in the implant, the controller comprising: a pressure sensor configured to acquire sensor data (e.g. Figure 1, Element 2 Column 3 lines 7-12 to measure pressure within the body); a processor having a sleep mode and an active mode (e.g. Figure 1, Element 12); and the controller is configured to, in responsive to the sensor data having a value outside of a predetermined interval, set the processor in the active mode (e.g. Column 1 lines 56-Column 2 line 4). However, Hoegnelid et al does not explicitly disclose the pressure sensor data is indicative of a pressure in a hydraulic system implanted in the patient.
Forsell teaches that it is known to use an implant comprising a pressure sensor in connection with at least one of a pump and a reservoir for determining a pressure in the reservoir and from the hydraulic pump as set forth in Paragraphs [0028], and [0832] to provide identifying the pressure in the reservoir or the hydraulic pump to identify changes that would potentially change the therapeutic effect of the device. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with an implant comprising a pressure sensor in connection with at least one of a pump and a reservoir for determining a pressure in the reservoir and from the hydraulic pump as taught by Forsell, since such a modification would provide the predictable results of identifying the pressure in the reservoir or the hydraulic pump to identify changes that would potentially change the therapeutic effect of the device.
Referring to Claim 44, Hoegnelid et al in view of Forsell teaches the implant according to claim 43, wherein: the sensor is a passive sensor; or the sensor a sensor with an energy consumption lower than the processor in the active mode (e.g. Column 4 lines 18-20 discloses a piezoelectric sensor that draws about 1µA).
Referring to Claim 45, Hoegnelid et al in view of Forsell teaches the implant according to claim 43, wherein: the sensor is configured to measure periodically (e.g. Column 3 lines 7-12 and Column 4 lines 18-20 discloses a piezoelectric sensor).
Referring to Claim 51, Hoegnelid et al in view of Forsell teaches the implant according to claim 43, wherein the pressure sensor is an analog sensor (e.g. Column 3 lines 7-12 and Column 4 lines 18-20).
Referring to Claim 57, Hoegnelid et al in view of Forsell teaches the implant according to claim 43, further comprising an active unit, communicatively coupled to the processor, for performing controlling or monitoring a bodily function in the patient (e.g. Column 3, lines 30-31 pacemaker).
Referring to Claim 58, Hoegnelid et al in view of Forsell teaches the implant according to claim 57, wherein: the active unit is configured to responsive to the sensor data having a value outside of the predetermined interval, perform the controlling or monitoring after the processor has been set in the active state (e.g. Column 4 lines 18-20 discloses activity sensor for pacemaker).
Claim(s) 52-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoegnelid et al (US Patent 5,350,412) in view of Forsell (US Publication 2015/0374906), as applied above, and further in view of Ostrow (US Patent 7,532,927).
Referring to Claim 52, Hoegnelid et al in view of Forsell teaches the implant according to claim 43, except further comprising a sensation generator configured to, upon request, generate a sensation detectable by a sense of the patient.
Ostrow teaches that it is known to use a sensation generator configured to, upon request, generate a sensation detectable by a sense of the patient; wherein the sensation generator is configured to receive the request, from a controller, in response to the sensor measurement having the value outside of the predetermined interval; wherein the sensation generator is configured to create the sensation or sensation components by at least one of: a vibration of the sensation generator; producing a sound; providing a photonic signal; providing a light signal; providing an electric signal; a heat signal as set forth in Figure 1, alert 104 (sensation generator) and Column 3 lines 5-32) to provide alerting the patient of the need to seek medical attention and/or cease exercise or other activities. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with a sensation generator configured to, upon request, generate a sensation detectable by a sense of the patient as taught by Ostrow, since such a modification would provide the predictable results of alerting the patient of the need to seek medical attention and/or cease exercise or other activities.
Referring to Claim 53, Hoegnelid et al in view of Forsell and Ostrow teaches the implant according to claim 52, except wherein the sensation generator is configured to receive the request from the controller of the implant.
Ostrow teaches that it is known to use a sensation generator configured to, upon request, generate a sensation detectable by a sense of the patient; wherein the sensation generator is configured to receive the request, from a controller, in response to the sensor measurement having the value outside of the predetermined interval; wherein the sensation generator is configured to create the sensation or sensation components by at least one of: a vibration of the sensation generator; producing a sound; providing a photonic signal; providing a light signal; providing an electric signal; a heat signal as set forth in Figure 1, alert 104 (sensation generator) and Column 3 lines 5-32) to provide alerting the patient of the need to seek medical attention and/or cease exercise or other activities. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with wherein the sensation generator is configured to receive the request from the controller of the implant as taught by Ostrow, since such a modification would provide the predictable results of alerting the patient of the need to seek medical attention and/or cease exercise or other activities.
Referring to Claim 54, Hoegnelid et al in view of Forsell and Ostrow teaches the implant according to claim 53, except wherein the request is generated by the controller in response to the sensor measurement having the value outside of the predetermined interval.
Ostrow teaches that it is known to use a sensation generator configured to, upon request, generate a sensation detectable by a sense of the patient; wherein the sensation generator is configured to receive the request, from a controller, in response to the sensor measurement having the value outside of the predetermined interval; wherein the sensation generator is configured to create the sensation or sensation components by at least one of: a vibration of the sensation generator; producing a sound; providing a photonic signal; providing a light signal; providing an electric signal; a heat signal as set forth in Figure 1, alert 104 (sensation generator) and Column 3 lines 5-32) to provide alerting the patient of the need to seek medical attention and/or cease exercise or other activities. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with the request is generated by the controller in response to the sensor measurement having the value outside of the predetermined interval as taught by Ostrow, since such a modification would provide the predictable results of alerting the patient of the need to seek medical attention and/or cease exercise or other activities.
Referring to Claim 55, Hoegnelid et al in view of Forsell and Ostrow teaches the implant according to claim 52, wherein the sensation generator is configured to receive the request from an external controller (e.g. Ostrow Figure 1, alert 104 (sensation generator) and Column 3 lines 5-32. The examiner notes that the functional language and statement of intended use has been carefully considered but are not considered to impart any further structural limitations over the prior art. Hoegnelid et al in view of Ostrow utilizes a sensation generator and is capable of being used in response to an external controller. In addition, nothing in the prior art prevents the sensation generator from being used with an external controller. Therefore, the sensation generator is capable of receiving the request form an external controller).
Referring to Claim 56, Hoegnelid et al in view of Forsell and Ostrow teaches the implant according to claim 52, except wherein the sensation generator is configured to create the sensation or sensation components by at least one of: a vibration of the sensation generator; producing a sound; providing a photonic signal; providing a light signal; providing an electric signal; a heat signal.
Ostrow teaches that it is known to use a sensation generator configured to, upon request, generate a sensation detectable by a sense of the patient; wherein the sensation generator is configured to receive the request, from a controller, in response to the sensor measurement having the value outside of the predetermined interval; wherein the sensation generator is configured to create the sensation or sensation components by at least one of: a vibration of the sensation generator; producing a sound; providing a photonic signal; providing a light signal; providing an electric signal; a heat signal as set forth in Figure 1, alert 104 (sensation generator) and Column 3 lines 5-32) to provide alerting the patient of the need to seek medical attention and/or cease exercise or other activities. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with the sensation generator is configured to create the sensation or sensation components by at least one of: a vibration of the sensation generator; producing a sound; providing a photonic signal; providing a light signal; providing an electric signal; a heat signal as taught by Ostrow, since such a modification would provide the predictable results of alerting the patient of the need to seek medical attention and/or cease exercise or other activities.
Claim(s) 59 and 63-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoegnelid et al (US Patent 5,350,412) in view of Forsell (US Publication 2015/0374906), as applied above, and further in view of Mondello et al (US Publication 2020/0305716).
Referring to Claim 59, Hoegnelid et al in view of Forsell teaches the implant according to claim 43, except wherein: the controller further comprises: a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit.
Mondello et al teaches that it is known to use a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit; a frequency detector (antenna), communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit; and an external controller, adapted to be arranged outside of the patient's body, configured to communicate with the communication unit as set forth in Figures 1 and 2; and Paragraphs [0003] and [0022]-[0023]; antenna 207 of implant 201 and external controller 203 to provide reduced risk of infection to the patient while enabling communication between an implant and an external device, where the implant can relay status information or receive commands to perform various operations in response. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit; a frequency detector (antenna), communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit; and an external controller, adapted to be arranged outside of the patient's body, configured to communicate with the communication unit as taught by Mondello et al, since such a modification would provide the predictable results of reduced risk of infection to the patient while enabling communication between an implant and an external device, where the implant can relay status information or receive commands to perform various operations in response.
Referring to Claim 63, Hoegnelid et al in view of Forsell and Mondello et al teaches the implant according to claim 59, except further comprising: a frequency detector, communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit.
Mondello et al teaches that it is known to use a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit; a frequency detector (antenna), communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit; and an external controller, adapted to be arranged outside of the patient's body, configured to communicate with the communication unit as set forth in Figures 1 and 2; and Paragraphs [0003] and [0022]-[0023]; antenna 207 of implant 201 and external controller 203 to provide reduced risk of infection to the patient while enabling communication between an implant and an external device, where the implant can relay status information or receive commands to perform various operations in response. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit; a frequency detector (antenna), communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit; and an external controller, adapted to be arranged outside of the patient's body, configured to communicate with the communication unit as taught by Mondello et al, since such a modification would provide the predictable results of reduced risk of infection to the patient while enabling communication between an implant and an external device, where the implant can relay status information or receive commands to perform various operations in response.
Referring to Claim 64, Hoegnelid et al in view of Forsell and Mondello et al teaches the implant according to claim 63, except wherein: the frequency detector comprises an antenna.
Mondello et al teaches that it is known to use a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit; a frequency detector (antenna), communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit; and an external controller, adapted to be arranged outside of the patient's body, configured to communicate with the communication unit as set forth in Figures 1 and 2; and Paragraphs [0003] and [0022]-[0023]; antenna 207 of implant 201 and external controller 203 to provide reduced risk of infection to the patient while enabling communication between an implant and an external device, where the implant can relay status information or receive commands to perform various operations in response. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit; a frequency detector (antenna), communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit; and an external controller, adapted to be arranged outside of the patient's body, configured to communicate with the communication unit as taught by Mondello et al, since such a modification would provide the predictable results of reduced risk of infection to the patient while enabling communication between an implant and an external device, where the implant can relay status information or receive commands to perform various operations in response.
Referring to Claim 65, Hoegnelid et al in view of Forsell and Mondello et al teaches a system comprising: the implant according to claim 59; an external controller, adapted to be arranged outside of the patient's body, configured to communicate with the communication unit. Mondello et al teaches that it is known to use a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit; a frequency detector (antenna), communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit; and an external controller, adapted to be arranged outside of the patient's body, configured to communicate with the communication unit as set forth in Figures 1 and 2; and Paragraphs [0003] and [0022]-[0023]; antenna 207 of implant 201 and external controller 203 to provide reduced risk of infection to the patient while enabling communication between an implant and an external device, where the implant can relay status information or receive commands to perform various operations in response. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with a communication unit communicatively coupled to the processor, wherein: the processor is configured to transmit data relating to the measurement via the communication unit; a frequency detector (antenna), communicatively coupled to the controller and configured to detect a frequency for data communication to or from the communication unit; and an external controller, adapted to be arranged outside of the patient's body, configured to communicate with the communication unit as taught by Mondello et al, since such a modification would provide the predictable results of reduced risk of infection to the patient while enabling communication between an implant and an external device, where the implant can relay status information or receive commands to perform various operations in response.
Claim(s) 60 and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoegnelid et al (US Patent 5,350,412) in view of Forsell (US Publication 2015/0374906) and Mondello et al (US Publication 2020/0305716), as applied in claim 59 above, and further in view of Cohen et al (US Publication 2014/0188398).
Referring to Claims 60 and 61, Hoegnelid et al in view of Forsell and Mondello et al teaches the implant according to claim 59, except wherein the processor is configured to: determine a cryptographic hash or a metadata relating to the sensor data and adapted to be used by an external device to verify the integrity of the received data, transmit, via the communication unit, the cryptographic hash or metadata, and transmit, via the communication unit, the sensor data; wherein the metadata comprises at least one of a length of the data and a timestamp, for verifying the integrity of the received sensor data.
Cohen et al teaches that it is known to use transmitting a cryptographic hash or metadata corresponding to the sent data and verifying, at the receiving device, the integrity of the data based on the cryptographic hash or metadata; wherein the metadata is a length of the data, a timestamp, or other data for verifying the integrity of the received measurement data as set forth in Paragraph [0140] to provide validating and verifying the integrity of the received data. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with transmitting a cryptographic hash or a metadata relating to the sensor data and adapted to be used by an external device to verify the integrity of the received data, transmit, via the communication unit, the cryptographic hash or metadata, and transmit, via the communication unit, the sensor data; wherein the metadata comprises at least one of a length of the data and a timestamp, for verifying the integrity of the received sensor data as taught by Cohen et al, since such a modification would provide the predictable results of validating and verifying the integrity of the received data.
Claim(s) 60 and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoegnelid et al (US Patent 5,350,412) in view of Forsell (US Publication 2015/0374906) and Mondello et al (US Publication 2020/0305716), as applied in claim 59 above, and further in view of Picco et al (US Publication 2019/0356492).
Referring to Claims 60 and 62, Hoegnelid et al in view of Forsell and Mondello et al teaches the implant according to claim 59, except wherein the processor is configured to: determine a cryptographic hash or a metadata relating to the sensor data and adapted to be used by an external device to verify the integrity of the received data, transmit, via the communication unit, the cryptographic hash or metadata, and transmit, via the communication unit, the sensor data; and wherein the sensor data is transmitted in a plurality of data packets, the cryptographic hash or metadata comprises a plurality of cryptographic hashes or metadata each corresponding to a respective data packet, and the transmitting of each the cryptographic hashes or metadata is performed for each of the corresponding data packets.
Picco et al teaches that it is known to use determine a cryptographic hash or a metadata relating to the sensor data and adapted to be used by an external device to verify the integrity of the received data, transmit, via the communication unit, the cryptographic hash or metadata, and transmit, via the communication unit, the sensor data; wherein the sensor data is transmitted in a plurality of data packets, the cryptographic hash or metadata comprises a plurality of cryptographic hashes or metadata each corresponding to a respective data packet, and the transmitting of each the cryptographic hashes or metadata is performed for each of the corresponding data packets; wherein the sensor data is transmitted in a plurality of data packets, the cryptographic hash or metadata comprises a plurality of cryptographic hashes or metadata each corresponding to a respective data packet, and the transmitting of each the cryptographic hashes or metadata is performed for each of the corresponding data packets as set forth in Figures 2 (415-418) and 3 (456-459 and 474-476) and Paragraph [0066] to provide improving validation protocol to ensure software components are not corrupted. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Hoegnelid et al, with determine a cryptographic hash or a metadata relating to the sensor data and adapted to be used by an external device to verify the integrity of the received data, transmit, via the communication unit, the cryptographic hash or metadata, and transmit, via the communication unit, the sensor data; wherein the sensor data is transmitted in a plurality of data packets, the cryptographic hash or metadata comprises a plurality of cryptographic hashes or metadata each corresponding to a respective data packet, and the transmitting of each the cryptographic hashes or metadata is performed for each of the corresponding data packets; wherein the sensor data is transmitted in a plurality of data packets, the cryptographic hash or metadata comprises a plurality of cryptographic hashes or metadata each corresponding to a respective data packet, and the transmitting of each the cryptographic hashes or metadata is performed for each of the corresponding data packets as taught by Picco et al, since such a modification would provide the predictable results of improving validation protocol to ensure software components are not corrupted.
Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoegnelid et al (US Patent 5,350,412) in view of Forsell (US Publication 2015/0374906), as applied above, and further in view of Fayram et al (US Publication 2006/0116590).
Referring to Claim 66, Hoegnelid et al in view of Forsell teaches the implant according to claim 43, except wherein the pressure sensor is a digital sensor. Fayram et al teaches that it is known to use a digital pressure sensor as set forth in Paragraph [0048] to provide a simple substitution of one known element for another producing a predictable result of obtaining pressure and feeding it into a processor without having a separate A/D converter. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Hoegnelid et al, with a digital pressure sensor as taught by Fayram et al, since such a modification would provide the predictable results of obtaining pressure and feeding it into a processor without having a separate A/D converter and is a simple substitution of one known element for another to obtain the predictable results of a pressure measurement.
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796