DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendments and remarks filed on 01/09/2026 have been fully considered.
Claims 18-19, 22 and 24-45 are pending for examination. Claims 1-17, 20-21 and 23 are cancelled.
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: “a control unit adapted to determine…” in claim 18; “at least one output interface…adapted to provide…” in claim 19; and “a control unit for determining” in claim 43.
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 § 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 1-45 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. Claims that depend directly or indirectly from claims 1, 18 and 33 is/are also rejected due to said dependency.
In regard to claims 18 and 33, the claims recite “the control unit is adapted for extrapolation of time-dependent data and for prediction of a tissue perfusion state/ extrapolating time-dependent data and predicting a tissue perfusion state”. It is unclear whether the recited “time-dependent data” refers to the data indicative of a tissue oxygen level, data indicative of an arterial blood oxygen level, or both or an additional data not related to the mentioned data. It is also unclear where the “predicting/ prediction of a tissue perfusion state” is related to/ based on the recited “changes in tissue perfusion”, “extrapolating time-dependent data”, “a measure for microcirculation” or a combination thereof or any other information. Clarification is requested by amendments. It is interpreted that they are independent functions/ steps not associated with any recited limitations for the purpose of compact prosecution.
In regard to claims 42, 43, 44 and 45, “the oxygen dissociation curve” lacks of sufficient basis.
In regard to claim 44, the claim does not include a period (.) in the end of the claim. It is unclear whether the claim is ended or there is/are missing limitations after “curve”. Clarification is requested by amendments.
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 18-19, 22, 24-38, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (USPGPUB 2015/0099955 – applicant cited) in view of Tschupp et al. (USPGPUB 2002/0062070 – applicant cited) and further in view of Andre et al. (USPGPUB 2012/0245439). In regard to claims 18, 24, 32-33 and 35, Al-Ali discloses a device and a method for obtaining an indicator of microcirculatory condition of a patient (Figs. 1-15 and associated descriptions; [0085-0088]; [0104]), comprising: at least one sensor for measuring data indicative of a tissue oxygen level being a first sensor element (regional oximetry sensors, Figs. 6 and 9-12 and associated descriptions; [0086-0087]; [0093]), at least one sensor for measuring data indicative of an arterial blood oxygen level, being a second sensor different from the first sensor element (Figs. 6 and 9-12 and associated descriptions; [0035]; oximeter, [0051]; Pulse CO-Oximetry, [0082]; a pulse oximetry measurement device, [0087]; regional oximetry sensors or peripheral arterial oxygen sensor, [0104]); and a control unit adapted to determine changes in tissue perfusion/ determine a measure for microcirculation on the basis of the tissue oxygen level and the arterial blood oxygen level (element 100, Figs. 2-3 and 9A and associated descriptions; a differential analysis of regional-to-central oxygen saturation, abstract; [0085]; [0087]; [0104]), wherein the second element comprises the second sensor element comprises a pulsoximetric sensor adapted for measuring the arterial blood oxygen level by optical detection of oxygen saturation (Figs. 6 and 9-12 and associated descriptions; [0035]; oximeter, [0051]; Pulse CO-Oximetry, [0082]; a pulse oximetry measurement device, [0087]; regional oximetry sensors or peripheral arterial oxygen sensor, [0104]).
Al-Ali does not specifically disclose the first sensor element comprises a transcutaneous measurement sensor , wherein the transcutaneous measurement sensor is adapted for heated transcutaneous measurement, wherein the control unit is adapted for indication of an arterial partial pressure of oxygen PaO2, and/or the control unit is adapted for indication of a transcutaneous partial pressure of oxygen PtcO2.
Tschupp teaches a device (Figs. 1-9 and associated descriptions) comprises an optical oximetry sensor (elements 2 and 3, Figs. 1-5 and associated descriptions) and a transcutaneous measurement sensor (elements 4/5/19, Figs. 1-4 and associated descriptions), wherein the transcutaneous measurement sensor is adapted for heated transcutaneous measurement (heating system 18, Fig. 3 and associated descriptions; [0045]), wherein the control unit is adapted for indication of an arterial partial pressure of oxygen PaO2, and/or the control unit is adapted for indication of a transcutaneous partial pressure of oxygen PO2 (transcutaneous measurement of oxygen partial pressure, [0045] and [0054]; screen, [0081]; digital output, abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first sensor element (Al-Ali) to incorporate the transcutaneous measurement sensor and associated elements/ functions/ configurations as taught by Tschupp, since both devices are oximetry systems and one or ordinary skill in the art would have recognized that the combination of optical oximetry sensor and transcutaneous measurement sensor facilitate obtaining more physiological information of the tissue site (see Tschupp). The rationale would have been to obtaining more physiological information of the tissue site.
Al-Ali as modified by Tschupp does not specifically disclose the control unit is adapted for extrapolation of time-dependent data and for prediction of a tissue perfusion state/ extrapolating time-dependent data and predicting a tissue perfusion state.
Andre teaches a physiological monitor device (Figs. 1-2, 5-11 and 29-36 and associated descriptions) comprises a control unit (elements 35/20/490, Figs. 1-2, 10-11 and 13 and associated descriptions) adapted for extrapolation of time-dependent data (extrapolated, [0120]) and for prediction of a tissue perfusion state ([0240]; [0243]). It is noted that the limitations are rejected as best understood, see the 35 USC 112(b) rejection above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and the method (Al-Ali as modified by Tschupp) to incorporate the processing functions as taught by Andre, since both devices are physiological monitoring systems which processing additional obtained physiological data/ parameters (see both Al-Ali and Andre). The rationale would have been to improve the functions of the computer/ processor and obtain more information about the patient.
In regard to claim 19, Al-Ali as modified by Tschupp and Andre discloses the control unit has at least one input for receiving a measured or estimated tissue oxygen level value, at least one input for receiving a measured or estimated arterial blood oxygen level value, and at least one output interface connectable to an output device and adapted to provide an indicator of a microcirculatory condition of a patient based on the received inputs (ports/ connections and display 104, Figs. 2-3, 9A and 10-12 and associated descriptions of Al-Ali).
In regard to claims 22, 38 and 40, Al-Ali as modified by Tschupp and Andre discloses at least one further sensor adapted for measuring data indicative of a carbon dioxide level, a pH-level and/or a temperature (pH and temperature, [0035]; elements 112/213, Fig. 1C and 2 and associated descriptions; [0050]; [0054] of Al-Ali; Figs. 1-2 and associated descriptions; temperature sensor, [0045]; pH and carbon dioxide partial pressure tcpCO2, [0044-0045] of Tschupp).
In regard to claim 25, Al-Ali as modified by Tschupp and Andre discloses the sensor for measuring data indicative of an arterial blood oxygen level and/or the sensor for measuring data indicative of a tissue oxygen level are adapted for continuous and/or intermittent and/or alternating measurements ([0085]; [0087] of Al-Ali).
In regard to claim 26, Al-Ali as modified by Tschupp and Andre discloses the sensor for measuring data indicative of an arterial blood oxygen level and the sensor for measuring data indicative of a tissue oxygen level are arranged in a common housing (oximetry platform, [0085] and [0087] of Al-Ali).
In regard to claim 27, Al-Ali as modified by Tschupp and Andre discloses the sensor for measuring data indicative of an arterial blood oxygen level and/or the sensor for measuring data indicative of a tissue oxygen level are adapted to be placed on a part of the skin (Figs. 6 and 9 and associated descriptions of Al-Ali).
In regard to claim 28, Al-Ali discloses as modified by Tschupp and Andre discloses the control unit is adapted for determining an indicator of a microcirculatory condition of a patient based on the difference between a first and a second oxygen level, the ratio of a first and a second oxygen level and/or an index based on a first and a second oxygen level (a differential analysis of regional-to-central oxygen saturation, abstract; [0085]; [0087]; [0104] of Al-Ali).
In regard to claim 29, Al-Ali as modified by Tschupp and Andre discloses the control unit is adapted for collecting, storing and processing time dependent data (memory, Fig. 3 and associated descriptions; trend information, Figs. 5, 7-8, and 10-15 and associated descriptions of Al-Ali).
In regard to claim 30, Al-Ali as modified by Tschupp and Andre discloses the control unit is adapted for determining changes in tissue perfusion on a predetermined and/or selectable timescale (Figs. 5, 7-8, and 10-15 and associated descriptions of Al-Ali).
In regard to claim 31, Al-Ali as modified by Tschupp and Andre discloses the control unit is connected or connectable to an output device, such as a monitor or a display for displaying the measure of microcirculation (Figs. 2-3 and associated descriptions of Al-Ali).
In regard to claim 34, Al-Ali as modified by Tschupp and Andre discloses the measure for microcirculation is determined in patients in a hospital (Figs. 6A and 6B and associated descriptions; [0032-0042]) but does not specifically disclose the patients are septic patients. One of ordinary skill in the art would have recognized that there are also needs for monitoring tissue microcirculation/ perfusion information of septic patients in a hospital. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method to septic patients in order to obtain tissue microcirculation/ perfusion information for them.
In regard to claim 36, Al-Ali as modified by Tschupp and Andre discloses the arterial blood oxygen level is measured by optical detection, and/or the tissue oxygen level is measured by a transcutaneous measurement (oximeter, [0051]; Pulse CO-Oximetry, [0082]; a pulse oximetry measurement device, [0087] of Al-Ali).
In regard to claim 37, Al-Ali as modified by Tschupp and Andre discloses wherein the arterial blood oxygen level is provided by pulsoximetric detection using two or more wavelengths (inherent properties of conventional oximeter; oximeter, [0051]; Pulse CO-Oximetry, [0082]; a pulse oximetry measurement device, [0087] of Al-Ali).
In regard to claim 41, Al-Ali as modified by Tschupp and Andre discloses a computer program for loading into a computer and/or for running on the computer, wherein the computer program is adapted for carrying out a method according to claim 33 (Figs. 3, 5, 7-8, and 10-15 and associated descriptions; [0058] of Al-Ali).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Tschupp and Andre as applied to claims 18-19, 22, 24-38, and 40-41 above, and further in view of Geva et al. (USPGPUB 2017/0027521 – cited in previous action). In regard to claim 39, Al- Ali as modified by Tschupp and Andre discloses providing data indicative of a carbon dioxide level, a pH-level and/or a temperature (pH and temperature, [0035]; elements 112/213, Fig. 1C and 2 and associated descriptions; [0050]; [0054] of Al-Ali) but does not specifically disclose the data are provided for correcting a pulsoximetric detection of the arterial blood oxygen level.
Geva teaches a device and a method for monitoring physiological parameters (Figs. 1-2 and associated descriptions) comprises an oxygen saturation sensor (element 110a, Figs. 1B and 1C and associated descriptions; [0059]) and temperature sensor (element 1120F, Fig. 2B and associated descriptions; [0060]), wherein the temperature is provided to correct for variations in oxygen saturations readings that may be influenced by the temperature of the tissue ([0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (Al-Ali as modified by Tschupp and Andre) to incorporate the temperature correcting method as taught by Geva, since both devices are oximetry systems and one of ordinary skill in the art would have recognized that tissue temperature can be utilized to correct variations in oxygen saturations readings (see Geva). The rationale would have been to obtain more accurate oxygen saturations readings.
Claims 42 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Al-Ali, Tschupp and Andre as applied to claims 18-19, 22, 24-38, and 40-41 above, and further in view of Fromage (USPGPUB 2013/0327330). In regard to claims 42 and 44, Al-Ali as modified by Tschupp and Andre discloses at least one further sensor adapted for measuring data indicative of a carbon dioxide level (referring to claims 18, 22, 33, 38, and 40 above; carbon dioxide partial pressure, [0044-0045] of Tschupp) but does not specifically disclose the arterial blood oxygen level is corrected, using the correlation between the carbon dioxide levels and the oxygen dissociation curve.
Fromage teaches the relationship between arterial oxygen saturation, SaO2, haemoglobin dissociation curve, arterial oxygen partial pressure, PaO2, and partial pressure of carbon dioxide, PaCO2 (Fig. 1 and associated descriptions; SaO2, Barcroft Curve and PaCO2, [0006]), wherein the dissociation curve varies depending on PaCO2 and SaO2 decreases when PaCO2 increases ([0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify device and method (Al-Ali as modified by Tschupp and Andre) to incorporate the known relationship as taught by Fromage and to correct the arterial oxygen saturation using the PaCO2-correlated/calibrated dissociation curve, since one of ordinary skill in the art would have recognized that the Barcroft curve/ hemoglobin dissociation curve varies according to the PaCO2 and arterial oxygen saturation decreases when PaCO2 increases (see Fromage). The rationale would have been to obtain more accurate arterial oxygen saturation.
Claims 43 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali in view of Tschupp and further in view of Fromage. In regard to claims 43 and 45, Al-Ali discloses a device and a method for obtaining an indicator of microcirculatory condition of a patient (Figs. 1-15 and associated descriptions; [0085-0088]; [0104]), comprising: at least one sensor for measuring data indicative of a tissue oxygen level being a first sensor element (regional oximetry sensors, Figs. 6 and 9-12 and associated descriptions; [0086-0087]; [0093]), at least one sensor for measuring data indicative of an arterial blood oxygen level, being a second sensor different from the first sensor element (Figs. 6 and 9-12 and associated descriptions; [0035]; oximeter, [0051]; Pulse CO-Oximetry, [0082]; a pulse oximetry measurement device, [0087]; regional oximetry sensors or peripheral arterial oxygen sensor, [0104]); and a control unit adapted to determine changes in tissue perfusion/ determine a measure for microcirculation on the basis of the tissue oxygen level and the arterial blood oxygen level (element 100, Figs. 2-3 and 9A and associated descriptions; a differential analysis of regional-to-central oxygen saturation, abstract; [0085]; [0087]; [0104]), wherein the second element comprises the second sensor element comprises a pulsoximetric sensor adapted for measuring the arterial blood oxygen level by optical detection of oxygen saturation (Figs. 6 and 9-12 and associated descriptions; [0035]; oximeter, [0051]; Pulse CO-Oximetry, [0082]; a pulse oximetry measurement device, [0087]; regional oximetry sensors or peripheral arterial oxygen sensor, [0104]).
Al-Ali does not specifically disclose the first sensor element comprises a transcutaneous measurement sensor and at least one further sensor adapted for measuring data indicative of a carbon dioxide level, a pH-level and/or a temperature (pH and temperature, [0035]; elements 112/213, Fig. 1C and 2 and associated descriptions; [0050]; [0054] of Al-Ali; Figs. 1-2 and associated descriptions; temperature sensor, [0045]; pH and carbon dioxide partial pressure tcpCO2, [0044-0045] of Tschupp.
Tschupp teaches a device (Figs. 1-9 and associated descriptions) comprises an optical oximetry sensor (elements 2 and 3, Figs. 1-5 and associated descriptions) and a transcutaneous measurement sensor (elements 4/5/19, Figs. 1-4 and associated descriptions) and at least one further sensor adapted for measuring data indicative of a carbon dioxide level (sensors, Figs. 1-2 and associated descriptions; pH and carbon dioxide partial pressure, [0044-0045])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first sensor element (Al-Ali) to incorporate the transcutaneous measurement sensor and associated elements/ functions/ configurations as taught by Tschupp, since both devices are oximetry systems and one or ordinary skill in the art would have recognized that the combination of optical oximetry sensor and transcutaneous measurement sensor facilitate obtaining more physiological information of the tissue site (see Tschupp). The rationale would have been to obtaining more physiological information of the tissue site.
Al-Ali as modified by Tschupp does not specifically disclose the arterial blood oxygen level is corrected, using the correlation between the carbon dioxide levels and the oxygen dissociation curve.
Fromage teaches the relationship between arterial oxygen saturation, SaO2, haemoglobin dissociation curve, arterial oxygen partial pressure, PaO2, and partial pressure of carbon dioxide, PaCO2 (Fig. 1 and associated descriptions; SaO2, Barcroft Curve and PaCO2, [0006]), wherein the dissociation curve varies depending on PaCO2 and SaO2 decreases when PaCO2 increases ([0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify device and method (Al-Ali as modified by Tschupp) to incorporate the known relationship as taught by Fromage and to correct the arterial oxygen saturation using the PaCO2-correlated/calibrated dissociation curve, since one of ordinary skill in the art would have recognized that the Barcroft curve/ hemoglobin dissociation curve varies according to the PaCO2 and arterial oxygen saturation decreases when PaCO2 increases (see Fromage). The rationale would have been to obtain more accurate arterial oxygen saturation.
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive. In regard to the claim interpretation, applicant alleged that the amendments of claim 18-19 recite sufficient structure to avoid being interpreted under 35 USC 112(f). In response, the amendments of claims 18-19 do not recite sufficient structures and the amended claim limitations are directed to use a generic placeholder that is coupled with functional language. See the claim interpretation section above.
Applicant’s amendment and argument with respect to claim 18 and new claims 43 and 45 filed on 01/09/2026 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
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.
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/CHU CHUAN LIU/ Primary Examiner, Art Unit 3791