DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Amendment, filed 24 September 2025, the status of the claims is as follows:
Claims 2 and 3 are as originally filed; and
Claims 1 and 4-23 are withdrawn.
Election/Restrictions
3. Applicant’s election without traverse of Species I, claims 2 and 3, in the reply filed on 24 September 2025 is acknowledged.
Claims 1 and 4-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
However, Applicant’s election was in error as claims 1, 7-9, and 13-19 were identified as generic in the Restriction/Election, p. 3, mailed 12 August 2025.
During a telephonic interview, on 12 November 2025, Examiner proposed to amend the withdrawn claims to claims 4-6, 10-12, and 20-23, and the elected claims to claims 1-3, 7-9, and 13-19. Applicant agreed to the proposed amendment to the election.
Thus, claims 1-3, 7-9, and 13-19 are elected for examination, and claims 4-6, 10-12, and 20-23 are withdrawn.
Claim Objections
4. Claim 9 is objected to because of the following informalities:
In line 1, “using both using” is a typographical error and should be amended to “using both.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
5. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
6. Claims 1-3, 7-9, and 13-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 1-3, 7-9, and 13-19 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process. Claims 6-10 are directed to a “device”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04 and the 2019 Revised Patent Subject Matter Eligibility Guidance, FR Vol. 84, No. 4, 07 January 2019):
Claim(s) 1-3, 7-9, and 13-19, recite the following mental process:
using the first and second oxygen measurements, and the CO2 measurement to determine partial pressure of oxygen in arterial blood (PaOz).
This abstract idea is not integrated into a practical application because the additional limitations of “obtaining a first oxygen measurement from exhaled breath of the patient; obtaining a second oxygen measurement of the patient from other than breath sampling; obtaining a CO2 measurement from the patient;” in claim 1, add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “obtaining a first oxygen measurement from exhaled breath of the patient; obtaining a second oxygen measurement of the patient from other than breath sampling; obtaining a CO2 measurement from the patient;” in claim 1. Such features add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
Furthermore, the additional claim limitations that are not directed to the mental process are “using a blood oxygen saturation monitor to obtain the second oxygen measurement” in claim 2, and “wherein the blood oxygen saturation monitor is a SpO2 monitor” in claim 3. Such features are conventional and routine in the art (for example, see Tehrani, U.S. Patent No. 4,909,259 A, issued on 20 March 1990, col. 5, ll. 9-18, and fig. 1), and add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
Additional claim limitations that are not directed to the mental process are “rendering an alarm signal based upon the first oxygen measurement falling above a pre-determined oxygen level threshold” in claim 13, and “rendering an alarm signal based upon the determined PaO2 falling below a pre-determined PaO2 threshold” in claim 14. Merely presenting, i.e. rendering an alarm signal, the result of the mental process of collecting and analyzing information, without more, is abstract as an ancillary part of the collection and analysis of the information.
The additional limitations of dependent claim, 7-9 and 13-19 are merely directed to and further narrow the scope of the mental process or further narrow the scope of the additional limitations that do not integrate the mental process into a practical application or are not significantly more than the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Claim Rejections - 35 USC § 102
7. 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.
8. 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.
9. Claims 1-3, 8, 13, 14, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heinonen, U.S. Patent Application Publication No. 2016/0058346 A1 (“Heinonen”).
As to Claim 1, Heinonen teaches the following:
A method of non-invasively using breathing metrics to determine an oxygen status of a patient (see “An embodiment of the method for monitoring a patient includes estimating an amount of carbon dioxide in arterial blood of a patient by noninvasively measuring an arterial oxygen saturation value for the patient, determining a breathing gas oxygen value, measuring a peak carbon dioxide partial pressure of a breathing gas expired by the patient and calculating an arterial blood carbon dioxide partial pressure of the patient based on at least the arterial oxygen saturation value, the breathing gas carbon dioxide value, and the breathing oxygen value for the patient.” in para. [0006]), comprising:
obtaining a first oxygen measurement from exhaled breath of the patient (see “The ventilator may have a gas analyzer 59 which may be configured to measure the breathing gas inspired and/or expired by the patient 53 in order to determine a breathing gas carbon dioxide value and a breathing gas oxygen value.” in para. [0028]);
obtaining a second oxygen measurement of the patient from other than breath sampling (see “The system 2 comprises a pulse oximeter 55 to measure hemoglobin oxygen saturation in the patient. The pulse oximeter 55 is connected to a finger probe 56 to make such measurement.” in para. [0028]);
obtaining a CO2 measurement from the patient (see “The ventilator may have a gas analyzer 59 which may be configured to measure the breathing gas inspired and/or expired by the patient 53 in order to determine a breathing gas carbon dioxide value and a breathing gas oxygen value.” in para. [0028]);
using the first and second oxygen measurements, and the CO2 measurement to determine partial pressure of oxygen in arterial blood (PaO2) (see “At step 22, the arterial oxygen partial pressure is calculated from the hemoglobin oxygen saturation measurement taken at step 20.” in para. [0019]; and see “The relationship between hemoglobin oxygen saturation and PaO.sub.2 is presented in FIG. 3. This relationship is known as the oxygen-hemoglobin dissociation curve. FIG. 3 presents the oxygen-hemoglobin dissociation curve 44, wherein the vertical coordinate 45 represents hemoglobin oxygen saturation and the horizontal coordinate 46 represents PaO.sub.2. Line 47 describes the relationship between hemoglobin oxygen saturation and PaO.sub.2 for a patient with a normal body pH. Line 48 is the relationship between hemoglobin oxygen saturation and PaO.sub.2 for a patient with a high body pH, whereas line 49 describes the relationship between hemoglobin oxygen saturation and PaO.sub.2 for a patient having a low body pH. From the appropriate oxygen hemoglobin dissociation curve 44, PaO.sub.2 is determined from a measured hemoglobin oxygen saturation value. For example, at an oxygen saturation of 90, the corresponding PaO.sub.2 value for a normal pH (7.4) is 7.9 kPa. On the other hand, for a patient having a pH of 7.0, which is an acidic pH (high PaCO.sub.2), the corresponding PaO.sub.2 value for an oxygen saturation of 90 is 12.2 kPa. For an alkaline patient having a pH of 7.8 (low PaCO.sub.2), the corresponding PaO.sub.2 value for an oxygen saturation of 90 is 5.0 kPa.” in para. [0020]).
As to Claim 2, Heinonen teaches the following:
using a blood oxygen saturation monitor (“pulse oximeter”) 55 to obtain the second oxygen measurement (see “FIG. 2 exhibits one embodiment of a method for noninvasively and continuously estimating the PaCO.sub.2 value for a patient. The hemoglobin oxygen saturation is measured at step 20, for example with a pulse oximeter. The pulse oximeter provides a noninvasive measurement of arterial blood hemoglobin oxygen saturation, and is typically taken from the periphery of a patient, such as from a fingertip or an earlobe. Such peripheral blood represents the same gas compartment as the blood leaving the lungs, i.e. PaO2. At step 22, the arterial oxygen partial pressure is calculated from the hemoglobin oxygen saturation measurement taken at step 20.” in para. [0019]).
As to Claim 3, Heinonen teaches the following:
wherein the blood oxygen saturation monitor is a SpO2 monitor (see “The hemoglobin oxygen saturation is measured at step 20, for example with a pulse oximeter. The pulse oximeter provides a noninvasive measurement of arterial blood hemoglobin oxygen saturation, and is typically taken from the periphery of a patient, such as from a fingertip or an earlobe.” in para. [0019]).
As to Claim 8, Heinonen teaches the following:
using a blood acidity measurement (pH) as an additional factor to determine PaO2 (see “Line 47 describes the relationship between hemoglobin oxygen saturation and PaO.sub.2 for a patient with a normal body pH. Line 48 is the relationship between hemoglobin oxygen saturation and PaO.sub.2 for a patient with a high body pH, whereas line 49 describes the relationship between hemoglobin oxygen saturation and PaO.sub.2 for a patient having a low body pH. From the appropriate oxygen hemoglobin dissociation curve 44, PaO.sub.2 is determined from a measured hemoglobin oxygen saturation value. For example, at an oxygen saturation of 90, the corresponding PaO.sub.2 value for a normal pH (7.4) is 7.9 kPa. On the other hand, for a patient having a pH of 7.0, which is an acidic pH (high PaCO.sub.2), the corresponding PaO.sub.2 value for an oxygen saturation of 90 is 12.2 kPa. For an alkaline patient having a pH of 7.8 (low PaCO.sub.2), the corresponding PaO.sub.2 value for an oxygen saturation of 90 is 5.0 kPa.” in para. [0020]).
As to Claim 13, Heinonen teaches the following:
rendering an alarm signal based upon the first oxygen measurement falling above a pre-determined oxygen level threshold (see “The user interface 63 may also be configured to generate an alert to alert a clinician that carbon dioxide concentrations in a patient are too high, such as if PaCO.sub.2 exceeds PetCO.sub.2 by more than a predetermined amount, or an arterial blood carbon dioxide indicator value exceeds a predetermined value.” in para. [0029]).
As to Claim 14, Heinonen teaches the following:
rendering an alarm signal based upon the determined PaO2 falling below a pre-determined PaO2 threshold (see “The user interface 63 may also be configured to generate an alert to alert a clinician that carbon dioxide concentrations in a patient are too high, such as if PaCO.sub.2 exceeds PetCO.sub.2 by more than a predetermined amount, or an arterial blood carbon dioxide indicator value exceeds a predetermined value.” in para. [0029]).
As to Claim 16, Heinonen teaches the following:
using a machine to render an indication of when the patient has reached the steady-state breathing (see “The user interface 63 may be configured to display values to a clinician, such as PaCO.sub.2, PetCO.sub.2, and/or arterial blood carbon dioxide indicator values.” in para. [0029]).
As to Claim 17, Heinonen teaches the following:
assisting a practitioner to evaluate the oxygen status of the patient by utilizing a baseline curve based on at least one of a patient’s age and medical condition (see “The relationship between hemoglobin oxygen saturation and PaO.sub.2 is presented in FIG. 3. This relationship is known as the oxygen-hemoglobin dissociation curve. FIG. 3 presents the oxygen-hemoglobin dissociation curve 44, wherein the vertical coordinate 45 represents hemoglobin oxygen saturation and the horizontal coordinate 46 represents PaO.sub.2.” in para. [0020]).
As to Claim 18, Heinonen teaches the following:
assisting a practitioner to evaluate the oxygen status by concurrently displaying PAO2, PACO2, PaO2, and PaCO2. (see “Furthermore, the exemplary patient monitoring system 2 may comprise a user interface 63. The user interface 63 may be configured to display values to a clinician, such as PaCO.sub.2, PetCO.sub.2, and/or arterial blood carbon dioxide indicator values.” in para. [0029]).
As to Claim 19, Heinonen teaches the following:
assisting a practitioner to evaluate the oxygen status by graphically displaying a composite alveolar oxygen value, a composite arterial oxygen value, and an oxygen deficit value (see “Furthermore, the exemplary patient monitoring system 2 may comprise a user interface 63. The user interface 63 may be configured to display values to a clinician, such as PaCO.sub.2, PetCO.sub.2, and/or arterial blood carbon dioxide indicator values.” in para. [0029]).
Claim Rejections - 35 USC § 103
10. 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.
11. 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.
12. Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Heinonen, as applied to claim 1 above, and further in view of Kahlman et al., European Patent No. 2948059 B2 (“Kahlman”).
As to Claim 7, Heinonen teaches the subject matter of claim 1 above. Heinonen does not teach the following:
using a temperature measurement as an additional factor to determine PaO2.
However, Kahlman teaches the following:
using a temperature measurement as an additional factor to determine PaO2 (see “An example of an Oxygen Dissociation Curve is shown in Fig. 1. Fig. 1 shows the variation in the curve (relationship between the partial oxygen pressure, pO2, and the oxygen saturation, sO2) with different pH values of 7.3, 7.4 and 7.5 at a temperature T of 37°C, and bicarbonate (HCO.sub.3.sup.-) concentration of 25 mmol/L. This can be corrected for a patient's temperature T.sub.P [°C] and the concentration HCO.sub.3 (bicarbonate ion) in [mmol/L] according to the Bohr Effect as follows: …” in para. [0071]; see equation (5) on page 10; and see “With reference to Fig. 1, it is observed that for adult people (under 55) without any respiratory conditions, oxygen saturation should be around 97 -100% (arterial partial oxygen pressure, PaO2 > 12 kPa), whereas for patient suffering from Chronic Obstructive Pulmonary Disease (COPD) oxygen saturation generally ranges between 88-92% (7.3 < Pa02 < 8.5 kPa) since, due to their condition, they are unable to expel carbon dioxide from their lungs and the carbon dioxide is retained.” in para. [0072]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Heinonen’s determination of to include a temperature measurement, as taught by Kahlman, because of the following advantage (see Kahlman, para. [0031]):
The present invention is based on the insight that intrinsic natural blood temperature differences and/or changes present in a subject to be monitored (or: a patient) may be utilized to determine oxygen saturation (SpO.sub.2) and its actual dependency on blood temperature. Thus, mere SpO.sub.2-detection can be extended to blood gas partial pressure measurement since, for instance, the relation among the SpO.sub.2 values and the corresponding temperature values can be considered in connection with a formal correlation such as the hemoglobin oxygen dissociation curve based on which the desired blood gas partial pressure can be derived. For instance, the determination of partial carbon dioxide pressure in the subject's arterial blood can be addressed. Furthermore, also the partial oxygen pressure can be an object of a measurement.
As to Claim 9, Heinonen teaches the subject matter of claim 1 above. Additionally, Heinonen teaches the following:
using … a blood acidity measurement (pH) as additional factors to determine PaO2 (see “Line 47 describes the relationship between hemoglobin oxygen saturation and PaO.sub.2 for a patient with a normal body pH. Line 48 is the relationship between hemoglobin oxygen saturation and PaO.sub.2 for a patient with a high body pH, whereas line 49 describes the relationship between hemoglobin oxygen saturation and PaO.sub.2 for a patient having a low body pH. From the appropriate oxygen hemoglobin dissociation curve 44, PaO.sub.2 is determined from a measured hemoglobin oxygen saturation value. For example, at an oxygen saturation of 90, the corresponding PaO.sub.2 value for a normal pH (7.4) is 7.9 kPa. On the other hand, for a patient having a pH of 7.0, which is an acidic pH (high PaCO.sub.2), the corresponding PaO.sub.2 value for an oxygen saturation of 90 is 12.2 kPa. For an alkaline patient having a pH of 7.8 (low PaCO.sub.2), the corresponding PaO.sub.2 value for an oxygen saturation of 90 is 5.0 kPa.” in para. [0020]).
Heinonen does not teach the following:
using … a temperature measurement to … determine PaO2.
However, Kahlman teaches the following:
using a temperature measurement to determine PaO2 (see “An example of an Oxygen Dissociation Curve is shown in Fig. 1. Fig. 1 shows the variation in the curve (relationship between the partial oxygen pressure, pO2, and the oxygen saturation, sO2) with different pH values of 7.3, 7.4 and 7.5 at a temperature T of 37°C, and bicarbonate (HCO.sub.3.sup.-) concentration of 25 mmol/L. This can be corrected for a patient's temperature T.sub.P [°C] and the concentration HCO.sub.3 (bicarbonate ion) in [mmol/L] according to the Bohr Effect as follows: …” in para. [0071]; see equation (5) on page 10; and see “With reference to Fig. 1, it is observed that for adult people (under 55) without any respiratory conditions, oxygen saturation should be around 97 -100% (arterial partial oxygen pressure, PaO2 > 12 kPa), whereas for patient suffering from Chronic Obstructive Pulmonary Disease (COPD) oxygen saturation generally ranges between 88-92% (7.3 < Pa02 < 8.5 kPa) since, due to their condition, they are unable to expel carbon dioxide from their lungs and the carbon dioxide is retained.” in para. [0072]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Heinonen’s determination of to include a temperature measurement, as taught by Kahlman, because of the following advantage (see Kahlman, para. [0031]):
The present invention is based on the insight that intrinsic natural blood temperature differences and/or changes present in a subject to be monitored (or: a patient) may be utilized to determine oxygen saturation (SpO.sub.2) and its actual dependency on blood temperature. Thus, mere SpO.sub.2-detection can be extended to blood gas partial pressure measurement since, for instance, the relation among the SpO.sub.2 values and the corresponding temperature values can be considered in connection with a formal correlation such as the hemoglobin oxygen dissociation curve based on which the desired blood gas partial pressure can be derived. For instance, the determination of partial carbon dioxide pressure in the subject's arterial blood can be addressed. Furthermore, also the partial oxygen pressure can be an object of a measurement.
12. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Heinonen, as applied to claim 1 above, and further in view of Binder, U.S. Patent No. 6,174,289 B1 (“Binder”).
As to Claim 15, Heinonen teaches the subject matter of claim 1 above. Heinonen does not teach the following:
using a flow volume loop to measure at least one of Forced Expiratory Volume (FEV), Forced Vital Capacity (FVC), and FEVi/FVC (FEV1%).
However, Binder teaches the following:
using a flow volume loop to measure at least one of Forced Expiratory Volume (FEV), Forced Vital Capacity (FVC), and FEV1/FVC (FEV1%) (see “Referring to FIG. 2, the patient preferably places the flow sensor 56 into his or her mouth, with or without a mouthpiece 143. If the mouthpiece 143 is used, it is attached to the adapter 54, preferably by a pressure fit against an inner surface 57 of the adapter 54.…” in col. 13, ll. 46-53; see “The patient then makes a maximum expiratory effort into the adapter 54. … The two most important variables measured during spirometer are Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC), which is the total exhaled breath volume during a maximum expiratory effort. The FEV1 and FVC measurements are well known in the medical literature. As stated above, the computer 18 determines the volume of the flow through the flow sensor 56 by integrating the measured flow rate with respect to time. The patient's maximum breathing capacity (MBC) is then calculated from the FEV1 measurement, based on published equations. Karlman Wasserman et. al., Principles of Exercise Testing and Interpretation at 79 (1984). The FEV1, FVC and MBC for that maximum expiratory effort are then displayed on the display 20.” in col. 13, l. 54, to col. 14, l. 3; and see “The data for the best trial are preferably displayed on the display 20 as a flow vs. volume curve, and the numerical values for FEV1 and FVC are shown on the graph as well as in tabular form with reference values and predicted values. The values of FEV1, FVC, and MBC are stored in the computer 18.” in col. 14, ll. 20-25).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Heinonen’s method to include using a flow volume loop to measure at least one of Forced Expiratory Volume (FEV) and Forced Vital Capacity (FVC), as taught by Binder, because of the following advantage (see Binder, see col. 13, ll. 9-19):
Spirometry data is used to calculate the patient's maximum breathing capacity (MBC) and is an excellent screening test for many pulmonary disorders. By integrating the ability to first make these resting measurements prior to performing an exercise test, then using this data to predict the patient's MBC, then assessing the ventilatory and gas exchange responses of a patient during exercise and comparing those responses to the patient's MBC, CPX is better able to distinguish pulmonary from cardiac causes of exercise limitation as well as make a more comprehensive evaluation of the respiratory system.
Conclusion
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 11/14/2025