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 .
Response to Amendment
This office action is in response to amendment filed 12/03/2025. As directed by the amendment, claims 2, 13, and 19-22 were canceled, claims 1 and 12 were amended, and claims 23-26 were newly added. Thus, claims 1, 3-12, 14-18, and 23-26 are presently pending in this application.
Claim Rejections - 35 USC § 103
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 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.
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 1, 3-6, 9-11, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol et al. (US 2010/0051025; hereinafter referred to solely as “Zapol”) in view of Goldstein et al (10,556,086; hereinafter “Goldstein”), Mulqueeny et al. (US 2016/0279361; hereinafter “Mulqueeny”), Dasse et al. (US 2017/0182088; hereinafter “Dasse”), Biondi (US 2007/0142716), Stamler et al. (US 6,472,390; hereinafter “Stamler”) and Bryan (US 2016/0361353).
Regarding claim 1, Zapol discloses a method for preventing an additive hemodynamic effect when treating a patient with a therapeutically effective amount of a pharmaceutical composition for treatment of hypertension (see Zapol [0003] Lines 1-2 “This invention relates to compositions and methods for preventing or reducing vasoconstriction”), the method comprising: co-administering with the pharmaceutical composition a therapeutically effective amount of inhaled nitric oxide (see Zapol Abstract Lines 4-8 “administering to a mammal a composition containing an artificial oxygen carrier in combination with one or more of a nitric oxide-releasing compound… a phosphodiesterase inhibitor”). Zapol is silent as to delivering in a pulsatile manner, wherein the inhaled nitric oxide is delivered in the pulsatile manner by: detecting a breath pattern in the patient including a total inspiratory time of a single breath utilizing a breath level trigger and a breath slope trigger; and delivering the inhaled nitric oxide to the patient in the pulsatile manner over a portion of the total inspiratory time of the single breath.
However, Goldstein teaches delivering in a pulsatile manner, wherein the inhaled nitric oxide is delivered in the pulsatile manner by (see Goldstein Claim 1 “A method of treating pulmonary hypertension, the method comprising: administering a plurality of pulses of therapeutic gas comprising nitric oxide (NO) to a patient”); detecting a breath pattern in the patient including a total inspiratory time of a single breath (see Goldstein Col. 7 Lines 8-11 “when a patient trigger sensor is used, it is possible for the system to determine the inspiratory and expiratory times in addition to the respiratory rate of the patient.”) utilizing a breath level trigger (see Goldstein Col. 6 Lines 60-67 patient trigger sensor, detects pressure drop indicating inspiration of the patient); and delivering the inhaled nitric oxide to the patient in the pulsatile manner over a portion of the total inspiratory time of the single breath (see Goldstein Col. 1 Lines 54-55 “the dose of nitric oxide is administered during inspiration”). Therefore, 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 of delivering the nitric oxide of Zapol with the method of delivering nitric oxide in a pulsatile manner as taught by Goldstein so as to have more control of the nitric oxide dosed to the patient to be more therapeutically effective, and treatment of certain conditions is more effective with pulsed administration, such as COPD (see Goldstein Col. 8 35-41).
Modified Zapol is silent as to also utilizing a breath slope trigger. However, Mulqueeny teaches an algorithm that utilizes a breath slope trigger (see Mulqueeny controller able to detect respiratory events… using [0229] “an inflection point indication maximum change in negative slope on the pressure at end expiration and immediately prior to triggering… (e) the inflection point indicating maximum change in positive slope on the flow signal during inspiration until the inspiratory peak”). Therefore, it would have been… to modify the algorithm of Goldstein with the addition of a breath slope trigger as well as taught by Mulqueeny so as to ensure the patient is properly inhaling before delivering the pulse, thus ensuring proper medication delivery.
Modified Zapol discloses monitoring a blood pressure of the patient (see Zapol [0096] “The effects of administration of gaseous nitric oxide…can be assessed by standard medical analyses. For example, systemic blood pressure can be monitored”). Modified Zapol is silent as to monitoring a heart rate of the patient, and an oxygen saturation of the patient. However, Dasse teaches a method and apparatus for administering nitric oxide with supplemental drugs (see Dasse title), wherein the method and apparatus are monitoring a heart rate of the patient, and an oxygen saturation of the patient (see Dasse [0209] pulse oximeter or multi-parameter patient monitor, measures oxygen saturation and pulse rate). Therefore, 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 patient parameter monitoring of modified Zapol with the ability to monitor patient oxygen saturation and heart rate as taught by Dasse so as to ensure patient safety and have more vital information.
Modified Zapol is silent as to discontinuing the co-administration of the pharmaceutical composition and nitric oxide when the blood pressure is below 90/55 mmHg. However, Biondi teaches the concept of discontinuing administration of a pharmaceutical composition, or blood pressure medication, when blood pressure is low (see Biondi [0017] “if a patient's blood pressure is decreasing, the infusion of blood pressure drugs can be decreased or stopped”). Furthermore, Stamler teaches the concept of discontinuing administration of nitric oxide when blood pressure is low (see Stamler Abstract “a therapeutically effective amount of a nitric oxide (NO) donor which is insufficient to acutely lower mean arterial blood pressure”). These concepts show that nitric oxide and the pharmaceutical composition are able to lower blood pressure, and to stop the treatment to prevent lowering blood pressure too low. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to discontinue the administration of the pharmaceutical composition and nitric oxide when blood pressure is below 90/55 mmHg, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Modified Zapol is silent as to discontinuing the administration of nitric oxide when syncope or lightheadedness is observed. However, Bryan teaches nitric oxide and PDE5 therapy (see Bryan title), and that syncope is a symptom of low blood pressure (see Bryan [0064] “side effects such as… low blood pressure leading to dizziness and syncope”). Previously, modified Zapol teaches discontinuing therapy when blood pressure is low. Therefore, 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 discontinuation of nitric oxide administration of modified Zapol when syncope is observed as taught by Bryan so as to avoid patient discomfort or harm.
Regarding claim 3, modified Zapol discloses the pharmaceutical composition is a PDE-5 inhibitor (see Zapol [0029] Lines 5-6 “a phosphodiesterase inhibitor (e.g., an inhibitor that is selective for cyclic guanosine monophosphate (cGMP) phosphodiesterase)”).
Regarding claim 4, modified Zapol discloses the PDE-5 inhibitor is sildenafil (see Zapol claim 47 “the phosphodiesterase inhibitor is sildenafil”).
Regarding claim 5, modified Zapol discloses the PDE-5 inhibitor is tadalafil (see Zapol Claim 47 “the phosphodiesterase inhibitor is tadalafil”).
Regarding claim 6, modified Zapol discloses the PDE-5 inhibitor is vardenafil (see Zapol Claim 47 “the phosphodiesterase inhibitor is vardenafil”).
Regarding claim 9, modified Zapol is silent as to the pharmaceutical composition is riociguat. However, Dasse teaches the pharmaceutical composition is riociguat (see Dasse Claim 46 “the anti-hypertensive drug is riociguat”). Therefore, 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 pharmaceutical composition of modified Zapol with the pharmaceutical composition of riociguat as taught by Dasse as this would have been an obvious substitution for one known pharmaceutical composition for another and would yield predictable results, i.e. administering the pharmaceutical composition of riociguat.
Regarding claim 10, modified Zapol discloses delivery of the dose of nitric oxide occurs within the first half of the total inspiratory time (see Goldstein Col. 5 Lines 58-59 “the pulse is administered during the first half of inspiration”).
Regarding claim 11, modified Zapol discloses the nitric oxide is delivered in a series of pulses over a period of time (see Goldstein Claim 12 “a plurality of pulses of the therapeutic gas is delivered to the patient”).
Regarding claim 23, modified Zapol does not explicitly disclose the portion of the total inspiratory time is a first third of the total inspiratory time, however Goldstein teaches the portion of the total inspiratory time is a first half of the total inspiratory time (see Goldstein Col. 5 lines 8-9 “the pulse is administered during the first half of inspiration”). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the portion of the total inspiratory time a first third of the total inspiratory time, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 25, modified Zapol discloses wherein delivery of the inhaled nitric oxide in the pulsatile manner directs the inhaled nitric oxide locally to lungs of the patient such that the additive hemodynamic effect is prevented (see Claim 1 where Zapol teaches safe administration to the respiratory system, as in the lungs, and methods of NO and a phosphodiesterase inhibitor administration, without any hemodynamic effect beyond controlled vasodilation. The delivery of this composition in the pulsatile manner taught by Goldstein is pulsed into the lungs as well as per the steps in claim 1. Additionally, the pulsatile manner taught by Goldstein is managed according to lung size [Col. 5 lines 48-40]).
Claims 12, 14-16, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol in view of Goldstein, Mulqueeny, Dasse, Bioni, Stamler, Bryan, and Henkin (US 2019/0231785).
Regarding claim 12, Zapol discloses a method for preventing a systemic, additive decrease in blood pressure in a patient being treated for hypertension while improving an overall treatment of said hypertension (see Zapol [0003] Lines 1-2 “This invention relates to compositions and methods for preventing or reducing vasoconstriction”), said method comprising co-administering a PDE-5 inhibitor and inhaled nitric oxide (see Zapol Abstract Lines 4-8 “administering to a mammal a composition containing an artificial oxygen carrier in combination with one or more of a nitric oxide-releasing compound… a phosphodiesterase inhibitor”). Zapol is silent as to delivering in a pulsate manner, wherein the inhaled nitric oxide is delivered in the pulsatile manner by: detecting a breath pattern in the patient including a total inspiratory time of a single breath utilizing a breath level trigger and a breath slope trigger; and delivering the nitric oxide to the patient in the pulsatile manner over a portion of the total inspiratory time of the single breath.
However, Goldstein teaches delivering in a pulsate manner, wherein the inhaled nitric oxide is delivered in the pulsatile manner by (see Goldstein Claim 1 “A method of treating pulmonary hypertension, the method comprising: administering a plurality of pulses of therapeutic gas comprising nitric oxide (NO) to a patient”); detecting a breath pattern in the patient including a total inspiratory time of a single breath (see Goldstein Col. 7 Lines 8-11 “when a patient trigger sensor is used, it is possible for the system to determine the inspiratory and expiratory times in addition to the respiratory rate of the patient.”) utilizing a breath level trigger (see Goldstein Col. 6 Lines 60-67 patient trigger sensor, detects pressure drop indicating inspiration of the patient); and delivering the inhaled nitric oxide to the patient in the pulsatile manner over a portion of the total inspiratory time of the single breath (see Goldstein Col. 1 Lines 54-55 “the dose of nitric oxide is administered during inspiration”). Therefore, 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 of delivering the nitric oxide of Zapol with the method of delivering nitric oxide in a pulsatile manner as taught by Goldstein so as to have more control of the nitric oxide dosed to the patient to be more therapeutically effective, and treatment of certain conditions is more effective with pulsed administration, such as COPD (see Goldstein Col. 8 35-41).
Modified Zapol is silent as to also utilizing a breath slope trigger. However, Mulqueeny teaches an algorithm that utilizes a breath slope trigger (see Mulqueeny controller able to detect respiratory events… using [0229] “an inflection point indication maximum change in negative slope on the pressure at end expiration and immediately prior to triggering… (e) the inflection point indicating maximum change in positive slope on the flow signal during inspiration until the inspiratory peak”). Therefore, it would have been… to modify the algorithm of Goldstein with the addition of a breath slope trigger as well as taught by Mulqueeny so as to ensure the patient is properly inhaling before delivering the pulse, thus ensuring proper medication delivery.
Modified Zapol discloses monitoring a blood pressure of the patient (see Zapol [0096] “The effects of administration of gaseous nitric oxide…can be assessed by standard medical analyses. For example, systemic blood pressure can be monitored”). Modified Zapol is silent as to monitoring a heart rate of the patient, and an oxygen saturation of the patient. However, Dasse teaches a method and apparatus for administering nitric oxide with supplemental drugs (see Dasse title), wherein the method and apparatus are monitoring a heart rate of the patient, and an oxygen saturation of the patient (see Dasse [0209] pulse oximeter or multi-parameter patient monitor, measures oxygen saturation and pulse rate). Therefore, 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 patient parameter monitoring of modified Zapol with the ability to monitor patient oxygen saturation and heart rate as taught by Dasse so as to ensure patient safety and have more vital information.
Modified Zapol is silent as to discontinuing the co-administration of the pharmaceutical composition and nitric oxide when the blood pressure is below 90/55 mmHg. However, Biondi teaches the concept of discontinuing administration of a pharmaceutical composition, or blood pressure medication, when blood pressure is low (see Biondi [0017] “if a patient's blood pressure is decreasing, the infusion of blood pressure drugs can be decreased or stopped”). Furthermore, Stamler teaches the concept of discontinuing administration of nitric oxide when blood pressure is low (see Stamler Abstract “a therapeutically effective amount of a nitric oxide (NO) donor which is insufficient to acutely lower mean arterial blood pressure”). These concepts show that nitric oxide and the pharmaceutical composition are able to lower blood pressure, and to stop the treatment to prevent lowering blood pressure too low. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to discontinue the administration of the pharmaceutical composition and nitric oxide when blood pressure is below 90/55 mmHg, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Modified Zapol is silent as to discontinuing the administration of nitric oxide when syncope or lightheadedness is observed. However, Bryan teaches nitric oxide and PDE5 therapy (see Bryan title), and that syncope is a symptom of low blood pressure (see Bryan [0064] “side effects such as… low blood pressure leading to dizziness and syncope”). Previously, modified Zapol teaches discontinuing therapy when blood pressure is low. Therefore, 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 discontinuation of nitric oxide administration of modified Zapol when syncope is observed as taught by Bryan so as to avoid patient discomfort or harm.
Modified Zapol is silent as to a dose of the pharmaceutical composition is about 10 mg to about 20 mg. However, Henkin teaches a dose of the pharmaceutical composition is about 10 mg to about 20 mg (see Henkin [0147-0148] “The nasal and/or pulmonary administered PDE inhibitors can be used at dose ranges”… about 100 mg per day, or 10 mg a day, which includes the range disclosed). Therefore, 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 pharmaceutical composition dose amount of modified Zapol with the dose amount as taught by Henkin as this would have been an obvious substitution for one known type of pharmaceutical composition dose for another and would yield predictable results, i.e. treat the patient with a proper dose of pharmaceutical composition for their treatment.
Regarding claim 14, modified Zapol discloses all of the claimed structures, see rejection to claim 4 above.
Regarding claim 15, modified Zapol discloses all of the claimed structures, see rejection to claim 5 above.
Regarding claim 16, modified Zapol discloses all of the claimed structures, see rejection to claim 6 above.
Regarding claim 26, modified Zapol discloses wherein delivery of the inhaled nitric oxide in the pulsatile manner directs the inhaled nitric oxide locally to lungs of the patient such that vasodilation is enhanced without causing systemic hypotension in the patient when co-administered with the PDE-5 inhibitor (see Claim 1 where Zapol teaches safe administration to the respiratory system, as in the lungs, and methods of NO and a phosphodiesterase inhibitor administration, without any hemodynamic effect, such as hypotension, beyond controlled vasodilation. The delivery of this composition in the pulsatile manner taught by Goldstein is pulsed into the lungs as well as per the steps in claim 1. Additionally, the pulsatile manner taught by Goldstein is managed according to lung size [Col. 5 lines 48-40]).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol, Goldstein, Mulqueeny, Dasse, Biondi, Stamler, and Bryan as applied to claim 3 above, and further in view of Perry et al. (US 2003/0070674; hereinafter referred to solely as “Perry”).
Regarding claim 7, modified Zapol is silent as to the PDE-5 inhibitor is a non-specific PDE-5 inhibitor. However, Perry teaches the PDE-5 inhibitor is a non-specific PDE-5 inhibitor (see Perry [0019] Lines 1-3, 16-17, 28 “The use of aerosolized nitric oxide donors requires simultaneous administration of a type V phosphodiesterase inhibitor to be effectual in any treatment platform… Phosphodiesterase inhibitors useful with the present invention include, and not limited to… Dipyridamole”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the PDE-5 inhibitors of Zapol with the non-specific PDE-5 inhibitor as taught by Perry because it appears the invention would perform equally as well with the simple substitution.
Regarding claim 8, modified Zapol discloses all of the claimed structures, see rejection to claim 7 above.
Claims 17-18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol, Goldstein, Mulqueeny, Dasse, Biondi, Stamler, Bryan, and Henkin as applied to claim 12 above, and further in view of Perry.
Regarding claim 17, modified Zapol discloses all of the claimed structures, see rejection to claim 7 above.
Regarding claim 18, modified Zapol discloses all of the claimed structures, see rejection to claim 7 above.
Regarding claim 24, modified Zapol discloses all of the claimed structures, see rejection to claim 23 above.
Response to Arguments
Applicant's arguments filed 12/03/2025 have been fully considered but they are not persuasive.
Applicant argues, on page 8 of the remarks, that “Zapol does not state that this inhibitor is co-administered with pulsatile inhaled nitric oxide.” Examiner disagrees, seeing as the claim language of “co-administering” in claim 1 line 4 can be interpreted as “the administration of two or more drugs together”. In Zapol, [0098] “A phosphodiesterase inhibitor can be administered in conjunction with nitric oxide”, thus disclosing a “co-administration” of at least two drugs within the administration. Any arguments regarding the “pulsatile manner” not being taught by Zapol are not persuasive, since a teaching reference Goldstein is used later in the rejection compared to the introduction of Zapol. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, the rejection still stands.
Applicant argues, on page 8 of the remarks, that “Goldstein does not teach or suggest co-administration of anything at all, let alone the pharmaceutical composition of independent claim 1”. However, Goldstein is not used to teach the co-administration of the pharmaceutical composition and nitric oxide, as this is taught by Zapol prior to the use of Goldstein in the rejection. Goldstein is merely used to teach the pulsatile manner of administration, and other subsequent limitations. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, the rejection still stands.
Applicant argues, on page 9 of the remarks, that “The Examiner's modification of Zapol with Goldstein constitutes impermissible hindsight… The Examiner's combination of Zapol and Goldstein includes knowledge that can only be gleaned from the present application. There is simply no teaching or suggestion in either Zapol or Goldstein that pulsatile delivery of inhaled nitric oxide in conjunction with a pharmaceutical composition for treatment of hypertension prevents an additive hemodynamic effect”. However, Examiner disagrees because Zapol teaches the conjunctive administration of inhaled nitric oxide with a pharmaceutical composition, specifically [0098] “A phosphodiesterase inhibitor can be administered in conjunction with nitric oxide”, where the purpose of the invention is to reduce vasoconstriction, which can be what causes hypertension. There is no additive hemodynamic effect because the method of Zapol is intended to treat the patient without causing additional ailments. An “additive hemodynamic effect” is a broad term interpreted in the present invention to be no added blood flow changes other than intended by the treatment.
Furthermore, the teachings of Zapol disclose co-administration of nitric oxide and a pharmaceutical composition, and the teaches of Goldstein modify that co-administration to be “in a pulsatile manner”. Both of these teachings take into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made. Additionally, Goldstein administers nitric oxide, which is in the same scope as the co-administration in Zapol. As Examiner interprets, MPEP 2145(X)(A) supports such a modification, as no knowledge was gleaned from the applicant’s disclosure since Zapol and Goldstein disclose all steps necessary in the claim. Therefore, the rejections still stand.
Applicant argues, on page 10 of the remarks, that Bryan teaches away from the independent claim. However, Examiner, on page 6 of the rejection, uses Bryan merely to teach syncope as a symptom of low blood pressure, and is in relation to a nitric oxide and PDE5 therapy administration. Bryan is not used to teach anything but a mere side effect disclosed that is already well known in the art to be a symptom of low blood pressure, wherein the present invention is a therapy intended to lower blood pressure. Therefore, the rejection still stands.
Applicant argues, on pages 11-12 of the remarks, that “Examiner's reliance on Henkin for a dose of a PDE-5 inhibitor to treat hypertension in conjunction with inhaled nitric oxide is impermissible hindsight. The Examiner has simply located a reference that teaches a dose of a PDE-5 inhibitor without accounting for the co-administration of nitric oxide.” However, Henkin is used to teach “a dose of the pharmaceutical composition is about 10mg to about 20mg” of previous claim 1 and “a dose of the PDE-5 inhibitor is about 10mg to about 20mg” of claim 12 line 16. Henkin, on pages 6-7 of the rejection, is used and cited to teach a PDE inhibitor dose range. The co-administration of inhaled nitric oxide is not claimed in this limitation, merely the dosage of the pharmaceutical composition. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, the rejection still stands.
Conclusion
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785 /TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785