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 .
Specification
The lengthy 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 Objections
Claims 10, 12, 16 are objected to because of the following informalities:
-Claim 10 recites “wherein the notification” in line 6. Examiner recommends amending to –and wherein the notification—
-Claim 12 recites “wherein setting” in line 4. Examiner recommends amending to –and wherein setting—
-Claim 16 recites “wherein performing” in line 6. Examiner recommends amending to –and wherein performing—
Appropriate correction is required.
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:
-Claims 10, 15, and 20 recites “a device” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to deliver therapy treatment to the subject. According to the specification the device includes a pacemaker, neurostimulator, drug pump, mechanical device [0015] and equivalents thereof.
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 12, 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 12 recites “a value of the one or more control parameters” in lines 3-4. It is unclear whether this is the same or different from “values of one or more control parameters” in claim 1, line 6.
-Claim 16 recites “the composite parameter value” in line 6. There is insufficient antecedent basis for this limitation in the claim. Should possibly read –the composite trigger value—
Claim Rejections - 35 USC § 101
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recites(s) a series of mental processes used to determine a control measure. This judicial exception is not integrated into a practical application because the processor is recited as performing the generic computer function of measuring, determining and comparing values and a control measure of a therapy system. The processor executing machine readable instructions and a process of measuring, determining and comparing these values is a generic function of computer-readable media. Further, mere instructions to apply a judicial exception using a generic control system does not impose meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements recited in claims 1-20 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition.
An analysis of the claims is shown below:
Step 1: Claims 1-18, 20 are directed towards a system, which is a statutory category of invention. Claim 19 is directed towards a method which is a statutory category of invention.
Step 2A, prong 1: Claim 1 recites limitations that are directed to an abstract idea. Claims 1, 19 and 20 recite perform a control measure. These limitations, under their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas. It would be practically performable in a human’s mind, or with pen and paper, to determine a control measure of a device. Analyzing information and making a determination based on information is akin to an observation, evaluation or judgement that defines the mental process grouping. Independent claims 1, 19 and 20 do not require use of a therapy system or any modification made to the system. While these claim limitations of do specify perform a control measure, this could equate to making a decision based on data collected. Thus claims 1, 19 and 20 are directed to a judicial exception, an abstract idea.
Step 2A, prong 2: Claims 1-20 do not recite additional elements that integrate the judicial exception into a practical application. Claims 1-20 recite the following additional elements:
-processor (claims 1, 3, 12, 16, 20)
-memory (claims 1, 20)
-one or more sensors (claims 1, 4, 5, 6, 7, 19, 20)
-optical sensor (claims 4, 5)
-ultrasound sensor (claim 4)
-impedance sensor (claim 6)
-subcutaneous blood pressure sensor (claim 7)
-device-pacemaker, neurostimulator, drug pump, or mechanical device (claim 11)
The processor, memory, one or more sensors, optical sensor, ultrasound sensor, impedance sensor, subcutaneous blood pressure sensor and device are generically recited at a high level of generality. Further, mere instructions or programs to apply judicial exception using a generic processors independently does not impose meaningful limits on practicing the abstract idea.
Most notably, none of the additional elements recited in these claims apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. While the bodies of these claims discuss aspects related to blood pressure, parameters related to anatomical diameters and flow, thyroid and kidney function there is no claim limitation the recites a particular treatment method.
Thus claims 1-20 do not integrate the abstract idea into a practical application.
Step 2B: When considered individually and in combination, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of the measure, determine, compare, perform additional control measures, deriving waveforms, delivering therapy treatment, outputting notifications, selecting modes of a device, setting a mode of a device, deriving composite trigger values, providing values to a machine learning model, and processing sets of values are also generically recited at a high level of generality. Mere determination or execution or control of a processor to apply a judicial exception using a generic settings of therapy treatment device does not impose meaningful limits on practicing the abstract idea. Furthermore, the processes and steps can be considered nonfunctional descriptive material because there are no elements that show how the modification of settings interacts with the processor of the therapy treatment device.
In reconsidering the additional elements of the therapy system and methods, the additional elements were determined to be well-understood, routine and conventional based on the following evidence:
-Gottesman et al. U.S. 20060122864 discloses a processor [Fig. 1, element 130], memory [0014], one or more sensors [Fig. 1, elements “Sensor 1, 2 and 3”], optical sensor [Pg. 4, “Optical Sensor”], ultrasound sensor [Pg. 4, “Ultrasound Sensor”], impedance sensor [Pg. 4, “Impedance Sensor”], subcutaneous blood pressure sensor [0014] and [Pg. 4, “Subcutaneous device”] and a device [Pg. 3, “Pacemaker, “Implantable Drug Pump” “Neuro-Cardiac Stimulator” and “Defibrillator”] in reference to a therapeutic device and method that utilizes blood pressure monitoring. Therefore, these elements are demonstrated to be generic, well understood components that are commonly recited in the art.
Claim Rejections - 35 USC § 102
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 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) 1-3, 5, 6, 9-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sandgaard (U.S. 20220202350).
Regarding Claim 1, Sandgaard teaches a system comprising:
a processor [Fig. 1, element 108 (processing circuitry)] and [0110]; and
a memory storing instructions thereon that [Fig. 1, element 124 (memory)] and [0092]—reference to microprocessors executing instructions stored on memory, when executed by the processor, cause the processor to:
measure, by one or more sensors, at least one biometric parameter associated with a subject [Fig. 2, element 204];
determine values of one or more control parameters based on measuring the at least one biometric parameter [Fig. 2, element 208]; and
perform a control measure based on a comparison of the values of the one or more control parameters to a threshold [Fig. 2, element 220].
Regarding Claim 2, Sandgaard teaches wherein:
determining the values of the one or more control parameters comprises deriving the values of the one or more control parameters based on measuring the at least one biometric parameter [0087]—reference to deriving physiological parameters to generate indicators and controls; and
the one or more control parameters comprise blood pressure of the subject [0087]—reference to blood pressure monitoring as particular physiological parameter monitors.
Regarding Claim 3, Sandgaard teaches wherein the instructions are further executable by the processor to:
perform a second control measure based on a set of data points associated with the at least one biometric parameter [Fig. 2, element 224]—reference to control and prompts for treatment devices and procedures.
Regarding Claim 5, Sandgaard teaches wherein:
the one or more sensors comprise an optical sensor [0093]—refers to use of optical sensors; and
the at least one biometric parameter comprises a characteristic of a pulse associated with an anatomical element of the subject [0093]—further discusses the use of pulse oximetry and [0090]—mentions the physiological metrics such as heart rate used.
Regarding Claim 6, Sandgaard teaches wherein:
the one or more sensors comprise an impedance sensor [0068] and [0073]; and
the at least one biometric parameter comprises a characteristic of a pulse of an impedance measurement associated with an anatomical element of the subject [0073]—refers to heart rate, photoplethysmography (PPG) and bioelectrical impedance measured across a chest of a patient.
Regarding Claim 9, Sandgaard teaches wherein:
the at least one biometric parameter comprises an optical signal associated with an anatomical element [0090] and [0093], an electrical impedance associated with the anatomical element, or a pressure associated with the anatomical element [0068] and [0073];
determining the values of the one or more control parameters comprises deriving a waveform representation of the optical signal, the electrical impedance, or the pressure [0087]-discusses derivation of physiological signals and [0113]—where reference sepsis index over time includes control parameters; and
performing the control measure is based on comparing one or more characteristics of the waveform representation to a set of threshold criteria [0114]—reference to threshold-based sepsis analysis.
Regarding Claim 10, Sandgaard teaches wherein performing the control measure comprises:
outputting a control signal to a device [0102]—reference to sensors outputting signals indicative of physiological parameters; and
at least one of: delivering, by the device, therapy treatment to the subject based on the control signal [Fig. 2, element 224], [Fig. 16, element 1620], [0140] and [0105];
and outputting, by the device, a notification based on the control signal, wherein the notification comprises an indication of one or more actions associated with treating a medical condition [Fig. 2, element 220], [Fig. 16, element 1624], [0140].
Regarding Claim 11, Sandgaard teaches wherein performing the control measure comprises:
selecting a mode of a device configured for delivering therapy treatment to the subject, the device comprising a pacemaker, a neurostimulator, a drug pump, or a mechanical device [0156]—reference to drug infusion pump; and
delivering the therapy treatment to the subject based on the mode [0157; “The sepsis monitor 106 may act as the master in the cooperative configuration where the sepsis monitor 106 receives additional monitoring data from the external device, and the sepsis monitor 106 generate signals to control the administration of the treatment.”].
Regarding Claim 12, Sandgaard teaches wherein the instructions are further executable by the processor to: set a mode associated with performing the control measure [0084]—reference to administered therapy applied based on sepsis indication and baseline non-septic values and therapy responding proportionally to increasing the therapy as septic condition declines,
wherein setting the mode is based on a value of the at least one biometric parameter, a value of the one or more control parameters, or both [0084]—references sepsis index, baseline, non-septic parameter values.
Regarding Claim 13, Sandgaard teaches wherein measuring the at least one biometric parameter,
determining the values of the one or more control parameters, and performing the control measure is in response to one or more trigger criteria [0071], [Fig. 2]—where is determining step is element 208, performing the control measure is element 224 and trigger criteria is elements 212 and 216.
Regarding Claim 14, Sandgaard teaches wherein the one or more trigger criteria comprise at least one of:
temporal criteria (not required by the claim);
a change in posture of the subject (not required by the claim);
a change in value of the at least one biometric parameter [Fig. 2, element 208, 212] and [0103]—reference to patient parameter changes which is interpreted to be changes in physiological parameters as collected from the sensors; and
a change in activity level or activity status associated with the subject [0153]—references brain activity.
Regarding Claim 15, Sandgaard teaches wherein the one or more trigger criteria comprise at least one of:
a control signal associated with delivering therapy treatment to the subject; and
delivery of the therapy treatment by a device [0084; “The therapy may respond to the sepsis index value in a proportional manner where a controlled feedback loop between the device produces the effect of increasing the therapy as a patient's septic condition declines. As the sepsis index returns towards 100, signifying patient's septic condition improving, the therapy can be reduced. Multiple therapies can be interlinked with the sepsis monitor with this method, such as a fluid volume monitor along the sepsis monitor and administration devices for antibiotics, vasopressors, and fluids.”]
Regarding Claim 16, Sandgaard teaches wherein:
the one or more trigger criteria comprise two or more trigger criteria [0132]—references sepsis scoring index steps repeating which would mean additional trigger criteria; and
the instructions are further executable by the processor to: derive a composite trigger value based on the two or more trigger criteria and respective weights of the two or more trigger criteria [0133; “Each monitored physiological parameter has an associated index coefficient (or multiplier) which is used to provide an appropriate weight of significance for the overall sepsis index value. As each monitored parameter changes away from its baseline, a percentage change is calculated (operation 1124) and the percentage change is multiplied by the parameter's associated coefficient to determine the parameter's impact on the sepsis index (operation 1128).”] ,
wherein performing the control measure is in response to the composite parameter value satisfying one or more threshold values [0103; “Operation 208 includes comparing the patient parameters from operation 204 to one or more thresholds… Operation 212 may be optionally performed to calculate patient parameter changes for the purpose of determining a sepsis index, where such sepsis index is used to determine the sepsis state of the patient 104.”]
Regarding Claim 17, Sandgaard teaches further comprising:
providing a set of values of the at least one biometric parameter to a machine learning model, wherein determining the values of the one or more control parameters comprises deriving, by the machine learning model, the values of the one or more control parameters in response to the machine learning model processing the set of values of the at least one biometric parameter [0082], [0098], and [0134].
Regarding Claim 18, Sandgaard teaches wherein measuring the at least one biometric parameter [0102],
determining the values of the one or more control parameters, and performing the control measure are associated with a closed loop operating mode of the system [0084]—reference to closed loop feedback detection and administration solution including sepsis index, septic conditions with therapy administration.
Regarding Claim 19, Sandgaard teaches a method comprising:
measuring, by one or more sensors, at least one biometric parameter associated with a subject [Fig. 2, element 204];
determining values of one or more control parameters based on measuring the at least one biometric parameter [Fig. 2, element 208]; and
performing a control measure based on a comparison of the values of the one or more control parameters to a threshold [Fig. 2, element 220].
Regarding Claim 20, Sandgaard teaches A system comprising:
one or more sensors [Fig. 1, element 112];
a device configured for delivering therapy treatment [Fig. 1, element 132];
a processor [Fig. 1, element 108]; and
a memory storing instructions thereon [Fig. 1, element 124] that, when executed by the processor, cause the processor to:
measure, by the one or more sensors, at least one biometric parameter associated with a subject [Fig. 2, element 204];
determine values of one or more control parameters based on measuring the at least one biometric parameter [Fig. 2, element 208]; and
perform a control measure via the device based on a comparison of the values of the one or more control parameters to a threshold [Fig. 2, element 220].
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandgaard (U.S. 20220202350) in view of Sverdlik (U.S. 20140012133).
Regarding Claim 4, Sandgaard teaches wherein:
the one or more sensors comprise an optical sensor [0024]—reference to optical sensor, an ultrasound sensor, or both; Sandgaard is silent on and the at least one biometric parameter comprises: a diameter associated with an anatomical element of the subject, a flow through the anatomical element, or both; or a pulse wave velocity value associated with the anatomical element. Sverdlik teaches and the at least one biometric parameter comprises: a diameter associated with an anatomical element of the subject [0005]—measure a diameter of the renal artery, a flow through the anatomical element [0004]—tracking arterial blood flow rate, or both; or a pulse wave velocity value associated with the anatomical element [0005]—pulse wave velocity of the renal artery.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use diameter, flow and pulse wave velocity measurements as taught by Sverdlik to measure and monitor biometric parameters as suggested by Sandgaard as Sandgaard discusses measuring plurality of physiological parameters indicative of sepsis with Sverdlik because Sverdlik teaches monitoring arterial stiffness to prevent hypertension, assess kidney function and determine correlations between blood pressure and kidney regulation [0078].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandgaard (U.S. 20220202350) in view of Garza (U.S. 20220022844).
Regarding Claim 7, Sandgaard is silent on wherein: the one or more sensors comprise a subcutaneous blood pressure sensor; the at least one biometric parameter comprises blood pressure associated with the subject; and the one or more control parameters comprise a characteristic associated with the blood pressure. Garza teaches wherein:
the one or more sensors comprise a subcutaneous blood pressure sensor [0009];
the at least one biometric parameter comprises blood pressure associated with the subject [0009];
and the one or more control parameters comprise a characteristic associated with the blood pressure [0067; “based on parameters determined in prior steps]—interpreted to be the control parameters and [Fig. 13, steps 194 and 195].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to calculate blood pressure characteristics based on control and previous data as taught by Garza to measure and monitor biometric parameters as suggested by Sandgaard as Sandgaard discusses the use of historical data while monitoring for sepsis [0134] with Garza because Garza teaches the use of this data to increase accuracy [0067].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandgaard (U.S. 20220202350) in view of Kommala (U.S. 20180353670).
Regarding Claim 8, Sandgaard teaches wherein the at least one biometric parameter comprises at least one of:
a pulse shape, a heart rate, blood volume, a flow rate, a pressure, or a combination thereof in association with an anatomical element of the subject [0073] and [0090]; Sandgaard is silent on and a first marker of a kidney function associated with blood pressure of the subject, a second marker of a thyroid function associated with the blood pressure, or a combination thereof.
Kommala teaches and a first marker of a kidney function associated with blood pressure of the subject, a second marker of a thyroid function associated with the blood pressure, or a combination thereof [0021]—reference to the use of glomerular filtration rate associated with blood pressure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to correlate blood pressure and physiological data with that of kidney function data based on control and previous data as taught by Kommala to measure and monitor biometric parameters as suggested by Sandgaard as Sandgaard discusses monitoring patients for life-threatening organ dysfunction [0057] with Kommala because Kommala teaches implementing a control variable when signs of kidney dysfunction are detected [0021].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Nappholz (U.S. 5188106)—reference a hemodynamic control system
-Bikia (U.S. 20220287640)-discusses a hemodynamic system using machine learning
-El-Khatib (WO 2022235714)-discloses a glucose control system for determining treatment
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791