DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment filed 20 February 2024 has been entered. Claim(s) 4-16 is/are currently amended. Claim(s) 1-17 is/are pending.
Specification
The disclosure is objected to because of the following informalities:
Applicant utilizes both "hypocortiolism" (e.g., Abstract, ¶ [0031] (as published), ¶ [0061]) and "hypocortisolism" (e.g., ¶¶ [0002]-[0004], ¶ [0008], ¶ [0062]) throughout the specification, presumably to refer to the same condition. The examiner is unable to determine if "hypocortiolism" is an acceptable, albeit less common, spelling of hypocortisolism or is misspelled. Regardless, for clarity, a single spelling should be used consistently throughout the application.
Paragraph [0063] contains several misspellings and/or typographical errors, e.g., "hart rate" should be corrected to "heart rate;" "(nor)epinefine" should be corrected to "(nor)epinephrine" or "norepinephrine;" each occurrence of "in the bod of the patient" should be corrected to "in the body of the patient;" etc.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which Applicant may become aware in the specification.
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 ("BRI") 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 BRI 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(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/069570 A1 ("Kendall").
Regarding claim 1, Kendall discloses a monitoring device (Abstract, system for detecting analytes in a biological subject, e.g., Fig. 7) for monitoring a hypocortisolism patient (intended use, see MPEP 2111.02), the monitoring device comprising:
a needle for penetrating a skin of the patient (microstructures 712/714, e.g., ¶ [0156]); and
an analysis module fluidly connected with the needle (monitoring device 720), the analysis module comprising:
a first sensor for measuring an inflammation level representative for the patient (sensor 321; ¶ [0184] analyte may comprise C-reactive protein, IL-6, etc.); and/or
a second sensor for measuring a stress level representative for the patient (sensor 321, e.g., ¶ [0363] where one or more analytes are detected; Table 1, where a detected analyte(s) may include cortisol, ACTH, etc.),
wherein the monitoring device configured to automatically trigger a notification in response to the first sensor measuring an inflammation level exceeding a first pre-defined threshold and/or in response to the second sensor measuring a stress level exceeding a second pre-defined threshold (e.g., ¶ [0273] audible alarms may be provided, for example providing an indication in the event that the subject has an analyte level or concentration outside an acceptable range).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-5, 7-9, 11 and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over "Management of Adrenocortical Insufficiency with Continuous Subcutaneous Hydrocortisone Infusion: Long-term Experience in Three Patients" ("Khanna"), as evidenced by "Paradigm Veo User Guide" ("Medtronic"), and in view of US 9,987,427 B1 ("Polsky").
Regarding claims 2-3, Khanna discloses/suggests an injection device for automatically administering a corticosteroid to a patient, the injection device (throughout document, pump, e.g., pg. 3, 554 Medtronic Pump) comprising:
a fluid container for storing an injection fluid, the injection fluid comprising or containing the corticosteroid (pg. 3, Efcortisol delivered via a continuous subcutaneous insulin infusion (CSII) 554 Medtronic Pump, which comprises a reservoir, see, Medtronic, pg. 2);
a needle for penetrating a skin of the patient, the needle being fluidly connected with the fluid container such that the injection fluid can be injected into the patient with the needle (means for infusing fluid from reservoir into the patient, e.g., pg. 2, invasive subcutaneous cannula; Medtronic, pg. 2, infusion set, which may comprise a cannula or needle (pg. 70));
a controller and an actuator communicatively coupled to the controller for forcing the injection fluid from the fluid container into the needle (e.g., Table 1, pg. 3, etc., means for controlling the pump to deliver fluid according to the basal rate or temporary basal rate, see, e.g., Medtronic, pgs. 105-113),
wherein the injection device is configured to:
automatically inject the injection fluid on more than one instance over the course of a 24h period, according to a pre-defined basic dosage regime (Table 1), and
automatically inject an additional dosage of the injection fluid on top of the basic dosage regime during periods of stress or illness (e.g., pg. 3, where the pumps were also set up with a temporary basal rate, which was double the usual rate of use, during periods of stress and minor illness).
While Khanna discloses automatically inject an additional dosage of the injection fluid on top of the basic dosage regime during periods of stress or illness as noted above, Khanna does not expressly disclose said dosage is injected in response to a first sensor measuring an inflammation level exceeding a first pre-defined threshold and/or in response to the second sensor measuring a stress level exceeding a second pre-defined threshold.
Polsky discloses an injection device (e.g., Fig. 2) comprising, inter alia, a fluid container for storing an injection fluid (col. 3, lines 7-12, depot, reservoir, etc.); a first sensor for measuring an inflammation level representative for the patient and a second sensor (col. 2, line 64 - col. 2, line 6, one or more sensing transducers, such as in an array, for performing real-time and repeated measurements for a variety of physiologically relevant analytes; col. 18, line 30 - col. 19, line 21, the one or more physiologically relevant markers may include an inflammatory marker (e.g., CRP)) and a second sensor for measuring a stress level representative for the patient (col. 2, line 64 - col. 2, line 6, one or more sensing transducers, such as in an array, for performing real-time and repeated measurements for a variety of physiologically relevant analytes; col. 18, line 30 - col. 19, line 21, the one or more physiologically relevant markers may include a hormone, such as adrenaline, and/or markers for stress or fatigue); a controller that is communicatively coupled to the first and second sensors and an actuator communicatively coupled to the controller for forcing the injection fluid from the fluid container into a needle for delivery to a patient (col. 24, lines 30-49, on-device circuitry and programmed algorithms; col. 23, lines 50-61, an appropriate quantity of a therapeutic agent is delivered by actuating one or more pumps; etc.), wherein the injection device is configured to automatically inject a dosage of an injection fluid in response to the first sensor measuring an inflammation level exceeding a first pre-defined threshold and/or in response to the second sensor measuring a stress level exceeding a second pre-defined threshold (e.g., col. 24, lines 30-49, wherein, if a measured concentration of a biomarker indicates delivery of a therapeutic agent is required, said agent is delivered; col. 23, lines 50-61; etc.).
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 injection device of Khanna with a first sensor for measuring an inflammation level representative for the patient and a second sensor for measuring a stress level representative for the patient; a controller communicatively coupled to the first and second sensors; and an actuator communicatively coupled to the controller for forcing the infusion fluid from the fluid container into the needle, wherein the injection device is configured to automatically inject an additional dosage of the injection fluid, on top of the basic dosage regime, in response to the first sensor measuring an inflammation level exceeding a first pre-defined threshold and/or in response to the second sensor measuring a stress level exceeding a second pre-defined threshold as taught/suggested by Polsky in order to facilitate automatically and/or intelligently managing periods of stress and illness in patients with adrenal insufficiency to aid in reducing hospital admissions attributable to adrenal crisis (Khanna, pg. 4; Polsky, col. 21, lines 29-45).
Regarding claim 4, Khanna as modified discloses/suggests at least one dosage of the pre-defined basic dosage regime is injected at an instance corresponding to 0-180 minutes before the patient is set to awake (e.g., Table 1, pg. 3, where infusion rates were considered in blocks, with the 0400–0900 h morning period being the peak infusion time, as in normal physiology).
Regarding claim 5, Khanna as modified discloses and/or suggests the corticosteroid is hydrocortisone (throughout document).
Regarding claim 7, Khanna as modified discloses/suggests the limitations of claim 2, as discussed above, and further discloses/suggests the basic dosage regime provides a dosage regime in a pattern that corresponds to a natural cortisol production regime in patients without hypo-cortisolism (pg. 2, CSHI mimics the normal physiological cortisol profile; pg. 5, CSHI maintains normal circadian variation of cortisol levels; etc.).
Regarding claim 8, Khanna as modified discloses/suggests the volume of the additional dosage corresponds to 1-10x the basic daily intake according to the pre-defined basic dosage regime (pg. 3, the temporary basal rate used during periods of stress and minor illness was double the usual rate).
Regarding claim 9, Khanna as modified discloses/suggests the first sensor measures inflammation level by monitoring the c-reactive protein, CRP, level in the body of the patient and/or the interleukin-6, IL-6, level in the body of the patient (Polsky, col. 18, line 30 - col. 19, where CRP is an inflammatory marker).
Regarding claim 11, Khanna as modified discloses/suggests the limitations of claim 2, as discussed above, but does not expressly disclose the device comprises a third sensor for measuring a corticoid level representative for the patient. However, Khanna does disclose/suggest measuring cortisol levels (pg. 3, patients were encouraged to provide samples for biochemical monitoring via either serum or salivary cortisol levels to enable the titration of HC infusion rates).
Polsky discloses the physiological relevant markers detected by the sensor array may further comprise cortisol (e.g., col. 18, line 30 - col. 19, line 21).
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 injection device of Khanna to further comprise a third sensor for measuring a corticoid level by monitoring cortisol level in the body of the patient as taught/suggested by Polsky in order to facilitate titration of corticosteroid infusion rates (Khanna, pg. 3).
Regarding claim 13, Khanna as modified discloses/suggests the injection device is wearable on the skin of the patient (see Medtronic, pg. 3, pgs. 67-68, etc.), e.g. on the arm, the leg, the abdomen, or another place, preferably a place where it can be hidden under clothes worn by the patient (although this limitation is optional or exemplary, see MPEP 2143.03, Khanna as modified further discloses/suggests said locations for wear, see, e.g., Medtronic, pgs. 67-68).
Regarding claims 14-15, Khanna as modified discloses/suggests the inflammation level and the stress level are obtained by bypassing interstitial fluid or blood of the patient through the injection device and across the first and second sensor (Fig. 2, col. 4, lines 41-51, etc.; col. 1, lines 55-65, where the sample fluid may be blood or interstitial fluid; etc.).
Regarding claim 16, Khanna as modified discloses/suggests the device comprises a patch configured to be worn on a skin of the patient (Polsky, col. 21, lines 29-45, wearable transdermal diagnostic/drug delivery device; col. 20, lines 21-29, the device is provided in combination with an adhesive layer to allow positioning the device on the skin of a subject), the patch comprising flow channels, in particular microchannels (Polsky, Fig. 2, channels), for transporting sweat of the patient towards the first and second sensors (Polsky, col. 3, lines 24-28, the device includes one or more fluidic channels, pumps, etc., configured to provide fluidic communication between the sensor and the sample), wherein the inflammation and stress level is obtained from said sweat (col. 5, lines 5-18, where the sample comprises sweat).
Regarding claim 17, Khanna discloses/suggests an injection assembly for automatically administering a corticosteroid to a patient, the injection assembly comprising
an injection member (throughout document, pump, e.g., pg. 3, 554 Medtronic Pump) comprising:
a fluid container for storing an injection fluid, the injection fluid comprising or containing the corticosteroid (pg. 3, Efcortisol delivered via a continuous subcutaneous insulin infusion (CSII) 554 Medtronic Pump, which comprises a reservoir, see, Medtronic, pg. 2);
a needle for penetrating a skin of the patient, the needle being fluidly connected with the fluid container such that the injection fluid can be injected into the patient with the needle (means for infusing fluid from reservoir into the patient, e.g., pg. 2, invasive subcutaneous cannula; Medtronic, pg. 2, infusion set, which may comprise a cannula or needle (pg. 70));
wherein the injection member is configured to automatically inject the injection fluid on more than one instance over the course of a 24h period, according to a pre-defined basic dosage regime (Table 1), and automatically inject an additional dosage of the injection fluid on top of the basic dosage regime during periods of stress or illness (e.g., pg. 3, where the pumps were also set up with a temporary basal rate, which was double the usual rate of use, during periods of stress and minor illness).
While Khanna discloses automatically inject an additional dosage of the injection fluid on top of the basic dosage regime during periods of stress or illness as noted above, Khanna does not disclose said dosage is injected in response to a first sensor measuring an inflammation level exceeding a first pre-defined threshold and/or in response to the second sensor measuring a stress level exceeding a second pre-defined threshold.
Polsky discloses an injection assembly (e.g., Fig. 2) comprising:
an injection member having a fluid container for storing an injection fluid (col. 3, lines 7-12, depot, reservoir, etc.) and a needle for penetrating a skin of the patient, the needle being fluidly connected with the fluid container such that the injection fluid can be injected into the patient with the needle (Fig. 2, second needle(s) associated with drug depots); and
a sensor member comprising a needle for penetrating a skin of the patient (Fig. 2, first needle(s) leading to sensor array), and an analysis module fluidly connected with the needle comprising at least a first sensor for measuring an inflammation level representative for the patient and a second sensor (col. 2, line 64 - col. 2, line 6, one or more sensing transducers, such as in an array, for performing real-time and repeated measurements for a variety of physiologically relevant analytes; col. 18, line 30 - col. 19, line 21, the one or more physiologically relevant markers may include an inflammatory marker (e.g., CRP)) and a second sensor for measuring a stress level representative for the patient (col. 2, line 64 - col. 2, line 6, one or more sensing transducers, such as in an array, for performing real-time and repeated measurements for a variety of physiologically relevant analytes; col. 18, line 30 - col. 19, line 21, the one or more physiologically relevant markers may include a hormone, such as adrenaline, and/or markers for stress or fatigue),
wherein the injection member is configured to automatically inject a dosage of an injection fluid in response to the first sensor measuring an inflammation level exceeding a first pre-defined threshold and/or in response to the second sensor measuring a stress level exceeding a second pre-defined threshold (e.g., col. 24, lines 30-49, wherein, if a measured concentration of a biomarker indicates delivery of a therapeutic agent is required, said agent is delivered; col. 23, lines 50-61; etc.).
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 injection assembly of Khanna with a sensor member comprising a needle for penetrating a skin of the patient and an analysis module fluidly connected with the needle, the analysis module comprising at least a first sensor for measuring an inflammation level representative for the patient and a second sensor for measuring a stress level representative for the patient, wherein the injection member is configured to automatically inject an additional dosage of the injection fluid, on top of the basic dosage regime, in response to the first sensor measuring an inflammation level exceeding a first pre-defined threshold and/or in response to the second sensor measuring a stress level exceeding a second pre-defined threshold as taught/suggested by Polsky in order to facilitate automatically and/or intelligently managing periods of stress and illness in patients with adrenal insufficiency to aid in reducing hospital admissions attributable to adrenal crisis (Khanna, pg. 4; Polsky, col. 21, lines 29-45).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khanna, as evidenced by Medtronic, in view of Polsky as applied to claim(s) 2 above, and further in view of "An Assessment of Optimal Hydrocortisone Replacement Therapy" ("Howlett").
Regarding claim 6, Khanna as modified discloses/suggests the limitations of claim 2, as discussed above, but does not disclose the basic dosage regime provides an active dosage of 10mg hydrocortisone at one instance over the course of the 24h period and two active dosages of 5 mg hydrocortisone at two different instances over the course of the 24h period.
Howlett discloses/suggests a basic dosage regime providing an active dosage of 10mg hydrocortisone at one instance over the course of the 24h period and two active dosages of 5 mg hydrocortisone at two different instances over the course of the 24h period is recommended as a starting dose (an appropriate starting dose of hydrocortisone of 10/5/5 mg (rising/lunch/evening) is suggested).
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 injection device of Khanna with the basic dosage regime providing an active dosage of 10mg hydrocortisone at one instance over the course of the 24h period and two active dosages of 5 mg hydrocortisone at two different instances over the course of the 24h period as taught/suggested by Howlett in order to provide a suitable starting dosage regime that may be adjusted/titrated for a specific patient (Khanna, pg. 3; Howlett, Conclusions).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khanna, as evidenced by Medtronic, in view of Polsky as applied to claim(s) 2 above; or alternatively, over Khanna, as evidenced by Medtronic, in view of Polsky as applied to claim(s) 2 above, and further in view of US 2013/0183243 A1 ("LaBelle").
Regarding claim 10, Khanna as modified discloses/suggests the limitations of claim 2, and discloses/suggests the device comprises a second sensor, as discussed above, and further discloses and/or suggests the second sensor measuring the stress level by monitoring the adrenaline level in the body of the patient and/or the noradrenaline level in the body of the patient (Polsky, col. 18, line 30 - col. 19, line 21, the one or more physiologically relevant markers may include adrenaline; col. 22, lines 19-46, where adrenaline is associated with exercise-induced exhaustion).
Alternatively/Additionally, LaBelle more expressly discloses/suggests adrenaline and/or noradrenaline (epinephrine and/or norepinephrine), or changes in adrenaline/noradrenaline levels relative to baseline as an indicator of stress (¶ [0064], ¶ [0099], Table 1). 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 injection device of Khanna with the second sensor measuring the stress level by monitoring the adrenaline and/or the noradrenaline level in the body of the patient as a simple substitution of one suitable stress marker/analyte by which to assess a need for stress dosing for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khanna, as evidenced by Medtronic, in view of Polsky as applied to claim(s) 2 above, and further in view of LaBelle.
Regarding claim 12, Khanna as modified discloses/suggests the limitations of claim 2, as discussed above, but does not expressly disclose the first and/or second pre-defined threshold for triggering the administration of the additional dosage corresponds to an increase of at least 50% of a respective, patient-specific, baseline inflammation and/or stress level.
LaBelle discloses a stress level marker, such as adrenaline and/or noradrenaline, may increase relative to a patient-specific, baseline level in conditions of stress (e.g., ¶ [0099], Table 1).
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 injection device of Khanna with the first and/or second pre-defined threshold for triggering the administration of the additional dosage corresponding to a pre-defined increase of a respective, patient-specific, baseline inflammation and/or stress level as taught/suggested by LaBelle in order to facilitate identifying periods of stress (LaBelle, ¶¶ [0099]-[0100]), during which additional corticosteroid should be administered (Khanna, pg. 3).
Khanna as modified does not expressly disclose the increase from the baseline level is at least 50%. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the injection device of Khanna with the pre-defined threshold being an increase of at least 50% from the patient's baseline level because Applicant has not disclosed that the threshold being at least 50% above baseline provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses the threshold may be set at other levels above the baseline level (e.g., ¶ [0064]). As no evidence has been provided to the contrary, one of ordinary skill in the art, would have expected Applicant's invention to perform equally well with the levels above baseline as taught/suggested by LaBelle because either arrangement facilitates identifying periods of stress.
Alternatively/Additionally, LaBelle discloses/suggests the amount of change in the stress marker relative to baseline is indicative of the degree and/or type of stress the person is under (e.g., ¶ [0099]). Since LaBelle discloses/suggests the threshold (e.g., amount above/below baseline) provides a quality which can be optimized (e.g., identifying/distinguishing a particular degree or type of stress), the specific claimed ranges of the marker being at least 50% higher than the baseline level would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791