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 .
Claim Objections
Claims 4, 8, 18, and 22 are objected to because of the following informalities:
In relation to claim 4, the claim uses "where" instead of "wherein" at the beginning. While not strictly an antecedent basis issue, this is inconsistent with the formatting of other claims which use "wherein." This should be "wherein" for consistency.
In relation to claim 8, the claim uses "where" instead of "wherein" at the beginning. While not strictly an antecedent basis issue, this is inconsistent with the formatting of other claims which use "wherein." This should be "wherein" for consistency.
In relation to claim 18, the claim uses "where" instead of "wherein" at the beginning. While not strictly an antecedent basis issue, this is inconsistent with the formatting of other claims which use "wherein." This should be "wherein" for consistency.
In relation to claim 22, the claim uses "where" instead of "wherein" at the beginning. While not strictly an antecedent basis issue, this is inconsistent with the formatting of other claims which use "wherein." This should be "wherein" for consistency.
Appropriate correction is required.
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 9 [and dependent claim 10] is 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.
In relation to claim 9, the claim recites: "[t]he device of claim 8, comprising an embedded RFID chip data information related to IDDS status." The phrase "comprising an embedded
RFID chip data information related to IDDS status" is grammatically awkward. It should
likely read "comprising an embedded RFID chip containing data information related to
IDDS status" or "comprising an embedded RFID chip with data information related to IDDS
status." As written, it's unclear whether "data information" is part of the RFID chip description or a separate element. This issue raises indefiniteness concerns under 112(b). Correction and/or clarification are respectfully requested.
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.
Claims 1, 2, 5, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Blackshear et al. (US 3,731,681; hereinafter “Blackshear”) in view of Miesel (US 2007/0255259A1).
Independent Claim 1 discloses:
"An implantable intrathecal drug delivery device comprising: a housing; a sensor assembly comprising: a compressible bellows enclosed by the housing, the bellows comprising a gas chamber filled with an inert gas; and a bellows sensor arm coupled to the bottom of the bellows and proximally aligned with a linear positional sensor; and a reservoir formed by an inner wall of the housing and an outer wall of the bellows; wherein the reservoir contains a fluid, and wherein the reservoir is in fluid connection with a catheter for delivery of the fluid to a terminal site."
In relation to independent claim 1, Blackshear discloses an implantable pump for infusing drugs or other chemicals into the body at a uniform slow flow rate (Abstract). The pump comprises a housing divided into two chambers separated by a bellows, diaphragm or other pressure-communicating interphase (Abstract). Specifically, Blackshear discloses an outer cylindrical housing (element 10) having a cylindrical side wall (11), circular bottom wall (12) and annular top wall (13) (Blackshear, Col. 1, lines 50-56).
Blackshear discloses a compressible bellows (element 18) positioned within the housing, comprised of a stack of concentric flat annular rings (19), a circular bottom wall (20), an annular top wall (21) and a cylindrical mouth or lip (22), forming an expandable contractible bellows structure (Blackshear, Col. 1, starting in line 62).
Blackshear discloses that the bellows comprises a gas chamber filled with an inert gas, specifically stating: "The outer pump chamber 23 at its minimum volume is partially filled with a stable volatile liquid that exerts a vapor pressure of greater than one atmosphere at physiological temperatures (approximately 37 C) to form the vapor-liquid mixture of the chemical power source" (Blackshear, Col. 3, lines 35-41). The volatile liquid creates a gas/vapor phase within the outer chamber 23, which is enclosed by the bellows structure.
Blackshear discloses a reservoir formed by an inner wall of the housing and an outer wall of the bellows, specifically stating: "Bellows 18 divides the interior of housing 10 into an outer chamber 23 and inner chamber 24 of varying volume" (Blackshear, Col. 2, lines 11-13) where "[t]he inner chamber 24 contains the displaceable infusate" (Blackshear, Col. 3, lines 48-49). Blackshear discloses that the reservoir contains a fluid, specifically the infusate (drug or chemical to be delivered) contained in inner chamber 24 (Blackshear, Col. 2, lines 11-23).
Blackshear discloses that the reservoir is in fluid connection with a catheter for delivery of the fluid to a terminal site, specifically stating: "One end of a thin small-diameter flexible capillary tube 40 (preferably within a larger protective tube) is secured in a radial discharge passage in the body of nipple 31 so as to be in direct fluid communication with the longitudinal passage through the nipple and with chamber 24 to serve as a discharge therefrom" (Blackshear, Col. 2, lines 62-68) and "[t]ubing 40 extends to the infusion site where the infused material is dispensed from its opposite end" (Blackshear, Col. 3, lines 5-7).
Blackshear does not explicitly disclose a bellows sensor arm coupled to the bottom of the bellows and proximally aligned with a linear positional sensor. However, Miesel discloses an implantable medical device for delivering therapeutic substance including a housing and a volume sensor assembly (Abstract). The volume sensor assembly includes a shaft having a first end attached to a base wall (which is movable relative to a stationary wall ([paragraph [0007]) and a second end maintaining a target movably arranged within a passage (Abstract). This shaft functions as a sensor arm coupled to the movable wall of the reservoir. Miesel discloses a linear positional sensor, specifically stating: "[t]he circuitry is associated with the cap and is adapted to generate information indicative of a longitudinal position of the target relative to a dimension of the cap" ([paragraph [0007]) and further stating: "the target is a ferromagnetic material and the circuitry includes a plurality of wire coils wound about an exterior of the cap, with inductance information generated by the wires being indicative of a position of the target" (para. [0007]). The wire coils function as a linear positional sensor that detects the longitudinal position of the target (and thus the shaft/sensor arm) to determine reservoir volume.
Based on the above teachings, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the teachings of Blackshear and Miesel. Both references are directed to implantable drug delivery devices for administering therapeutic substances to patients. A person of ordinary skill in the art would have been motivated to incorporate the volume sensor assembly of Miesel (comprising a sensor arm/shaft coupled to a movable wall and a linear positional sensor) into the bellows-based pump of Blackshear to provide a means for monitoring the amount of drug remaining in the reservoir.
In relation to claim 2, Blackshear discloses a device configured to deliver fluids at a fixed flow rate, specifically stating the pump is for "infusing drugs or other chemicals or solutions into the body at a uniform slow flow rate" (Abstract). Blackshear further explains: "[t]he flow rate of the infusate is varied through the use of the capillary tubing 40 for the pressure drop, which is governed by the equation: Q (πD4ΔP)/l28µL" (Blackshear, Col. 3, lines 50-55) and states "The most readily adjustable parameters are the length and diameter of the capillary and the viscosity of the infusate" (Blackshear, Col. 3, lines 55-57). Once the capillary dimensions are set, the flow rate remains fixed and constant during operation.
Since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
In relation to claim 5, as applied to Claim 1, Miesel discloses a sensor assembly configured to
detect reservoir volume by detecting the position of a movable wall. Miesel states: "[t]he circuitry is adapted to generate information indicative of a longitudinal position of the target relative to a
dimension of the cap” (Miesel, paragraph [0033]), which correlates with the reservoir volume (para. [0031]). In the combined system of Blackshear and Miesel, when the bellows of Blackshear is fully expanded, the inner chamber 24 (reservoir) would be at minimum volume (empty), and when the bellows is fully compressed, the inner chamber 24 would be at maximum volume (full). The sensor assembly of Miesel would detect these states by tracking the longitudinal position of the shaft attached to the bellows bottom wall. This detection of expanded or compressed states to determine reservoir volume would have been an obvious and predictable result of combining the teachings of Blackshear and Miesel.
In relation to claim 11, Blackshear discloses a puncturable septum in fluid communication with the reservoir, specifically stating: "[t]he upper portion 34 of nipple 31...receives a plug or stopper 38
formed of elastic self-puncture-sealing material, which serves as an entry port to chamber 24" (Blackshear, column 2, lines 33-41). Blackshear further states: "[r]efills of infusate are injected into the inner chamber through the self-sealing stopper 38" (Blackshear, Col. 3, lines 57-59). The stopper 38 is in direct fluid communication with inner chamber 24 (the reservoir) through longitudinal passage 37 in nipple 31. Since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Blackshear et al. (US 3,731,681; hereinafter “Blackshear”) in view of Miesel (US 2007/0255259A1), as discussed above, and in further view of Nat (US 2006/0129138A1).
In relation to claim 3, Blackshear discloses a capillary tube (40) in fluid connection with the reservoir (inner chamber 24) for restrictive flow, stating: "[o]ne end of a thin small-diameter flexible capillary tube 40...is secured in a radial discharge passage...so as to be in direct fluid communication ...with chamber 24" (Blackshear, Col. 2, lines 62-67) and "[t]he capillary tubing 40 serves a two-fold function, as a flow-regulating resistance element and a discharge port" (Blackshear, Col. 3, lines 10-12). Blackshear does not explicitly disclose that the capillary channel is microfabricated. Nat discloses an implantable drug delivery system with a microfabricated flow channel connected to a collapsible reservoir, stating: "[t]he microfabricated flow channel is connected at one end to the collapsible reservoir and opens at an external surface of the housing" (Abstract). Nat's microfabricated channel provides restrictive flow control for drug delivery. Accordingly, it would have been obvious to one of ordinary skill to fabricate the capillary channel of Blackshear using microfabrication techniques as taught by Nat. Both references address flow control in implantable drug delivery devices. Microfabrication techniques were well-known in the art for creating precise, miniaturized flow channels with controlled dimensions. Using microfabrication would have provided more precise flow control and enable device miniaturization, which are predictable benefits in the field of implantable medical devices.
8. Claim 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Blackshear et al. (US 3,731,681; hereinafter “Blackshear”) in view of Miesel (US 2007/0255259A1), as discussed above, and in further view of Burke et al. (US 6,764,472B1; hereinafter “Burke”), Nat (US 2006/0129138A1), and Silverman (US 6,221,056).
In relation to claim 4, Blackshear discloses that the bellows structure can be replaced by alternative flexible structures, stating: "[b]ellows 18 is one form of liquid-tight, vapor-tight, pressure communicating interphase means which can be used to separate the two chambers of the pump.” Alternatively, the chambers may be separated by a resilient diaphragm which is compatible with the substances within the chambers; or the second chamber may be formed, in part at least, from a flexible bladder which is compatible with the materials and capable of expanding and contracting" (Blackshear, Col. 3, lines 22-30).
Burke explicitly discloses that the variable volume chamber may be "a non-stretchable flexible bag" as an alternative to the bellows structure (Abstract). Burke also discloses that elastomeric materials can be used, as the device includes components made of materials compatible with body fluids and capable of expansion and contraction (Burke, Col. 9, lines 16-19).
Nat further discloses the use of "elastomeric block" and "elastomeric membrane" in drug delivery devices (see Nat, paragraph [0011]).
Based on the above comments, it would have been obvious to one of ordinary skill to implement the reservoir of Blackshear using an elastomeric bladder as suggested by Blackshear itself and as explicitly taught by Burke and Nat. The use of elastomeric materials for flexible, expandable reservoirs in implantable devices was well-known in the art at the time of filing and would have provided predictable
benefits of biocompatibility and reliable expansion/contraction cycles.
In relation to claim 12, Blackshear discloses a puncturable septum (stopper 38) but does not explicitly disclose a raised rim for palpation. While Blackshear does not explicitly describe a raised rim, the use of raised rims around puncturable septa would have been considered a modification of the shape of a well-known structure. Moreover, Silverman discloses in column 12, line 28, a raised rim, demonstrating the conventionality of this shape modification of a septum. Accordingly, since this enhancement was well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
8. Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Blackshear et al. (US 3,731,681; hereinafter “Blackshear”) in view of Miesel (US 2007/0255259A1), as discussed above, and in further view of Stevenson (US 2006/0212096A1).
In relation to claim 8, Stevenson discloses a radio frequency identification (RFID) system for use with active implantable medical devices (AIMD) including drug pumps (para. [0011]). Stevenson discloses a data information storage medium in the form of an RFID tag comprising a substrate, an RFID chip, and an antenna (Abstract). Additionally, Stevenson discloses that data information can be retrieved transcutaneously using an external transponder: a hermetically sealed radio frequency identification (RFID) system for use with active implantable medical devices (AIMD) implanted in a patient comprises an interrogator and an RFID tag (Abstract) and "[t]he RFID tag may store information about an AIMD including manufacturer, model number and serial number. The RFID tag may also store information about a treating physician and/or patient" (Abstract). The interrogator functions as an external transponder that communicates transcutaneously with the implanted RFID tag to retrieve stored data. Stevenson explicitly states that such RFID systems can be used with "a drug pump" among other implantable medical devices (para. [0011]).
Based on the teachings above, it would have been obvious to one of ordinary skill in the art to incorporate the RFID data storage and retrieval system of Stevenson into the implantable drug pump of
Blackshear/Miesel. Both references address implantable medical devices requiring identification and data storage. A person of ordinary skill would have been motivated to add RFID capability to enable transcutaneous retrieval of device information. This would have provided predictable benefits for device tracking, patient safety, and clinical management.
In relation to claim 9, Stevenson discloses an embedded RFID chip that stores data information related to implantable device status. Stevenson states: "[t]he RFID tag may store information about an
AIMD including manufacturer, model number and serial number" (Abstract) and can also store "information about a treating physician and/or patient including the treating physician's name and contact information, the patient's name, contact information, medical condition, treatment and other relevant information" (abstract). This encompasses device status information for an implantable drug delivery system (IDDS). Since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
In relation to claim 10, Miesel discloses that the sensor assembly generates information indicative of reservoir volume, stating: "[t]he circuitry is adapted to generate information indicative of a longitudinal position of the target relative to a dimension of the cap, which correlates with the reservoir volume" (Miesel, paragraph [0008]). This volume information can be stored in memory within the device. Additionally, Stevenson discloses that the RFID system can store and retrieve various types of device information transcutaneously using an external interrogator/transponder (Abstract).
Based on the above teachings, it would have been obvious to one of ordinary skill to configure the RFID system of Stevenson to store and transmit the reservoir volume data generated by the sensor assembly of Miesel. Both references address data storage and retrieval in implantable medical devices. Storing and retrieving reservoir volume information would provide the predictable benefit of allowing clinicians to check remaining drug supply transcutaneously without needle access, improving patient safety and clinical management.
Claims 15, 16, 19, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Burke et al. (US 6,764,472; hereinafter “Burke”) in view of Miesel (US 2007/0255259A1).
Independent claim 15 discloses:
"An implantable intrathecal drug delivery device comprising: a housing; a sensor assembly
comprising: a compressible bellows enclosed by the housing, the bellows forming a reservoir for a fluid to be delivered by the device; and a bellows reservoir sensor arm coupled to the bottom of the bellows and proximally aligned with a linear positional sensor; and a chamber formed by an inner wall of the housing and an outer wall of the bellows filled with an inert gas; wherein the reservoir contains a fluid, and wherein the reservoir is in fluid connection with a catheter for delivery of the fluid to a terminal site."
In relation to claim 15, Burke discloses an implantable infusion device including a housing which contains an infusate for administration to a patient (Abstract). The housing is described as "a lightweight, inert housing" (Abstract).
Burke discloses a compressible bellows enclosed by the housing, specifically stating: "an
enclosed, gas-impermeable variable volume chamber which contains a pressure source, such as propellant, mechanical spring, or the like. The variable volume chamber may be in the form of a rigid-walled expandable bellows structure" (Abstract).
Burke discloses an embodiment where the bellows forms a reservoir for fluid to be delivered. While Burke's primary embodiment shows the bellows containing the propellant with infusate external to the bellows, Burke also describes that "[t]he variable volume chamber may be in the form of a rigid-walled expandable bellows structure or a non-stretchable flexible bag" and that the infusate can be contained within various configurations (Abstract).
Burke discloses a chamber formed by an inner wall of the housing and an outer wall of
the bellows filled with an inert gas (propellant), stating: "[t]he variable volume chamber...contains a pressure source, such as propellant" (Abstract) and "a multiple-phase fluid propellant is present in at least one of a liquid phase and a gas phase within the variable volume region of the bellows as a function of ambient temperature" (Col. 3, starting in line 67). Burke discloses that the reservoir contains a fluid (the infusate for administration) (Abstract). Burke discloses that the reservoir is in fluid connection with a catheter for delivery, stating: "[t]he infusate is delivered from the device via a catheter in response to expansion of the variable volume chamber against the volume of infusate in the housing" (Abstract). Burke does not explicitly disclose a bellows reservoir sensor arm coupled to the bottom of the bellows and proximally aligned with a linear positional sensor.
As applied to Claim 1 above, Miesel discloses an implantable medical device for delivering therapeutic substance including a housing and a volume sensor assembly (Abstract). The volume sensor assembly includes a shaft having a first end attached to a base wall (which is movable relative to a stationary wall ([paragraph [0007]) and a second end maintaining a target movably arranged within a passage (Abstract). This shaft functions as a sensor arm coupled to the movable wall of the reservoir. Miesel discloses a linear positional sensor, specifically stating: "[t]he circuitry is associated with the cap and is adapted to generate information indicative of a longitudinal position of the target relative to a dimension of the cap" ([paragraph [0007]) and further stating: "the target is a ferromagnetic material and the circuitry includes a plurality of wire coils wound about an exterior of the cap, with inductance information generated by the wires being indicative of a position of the target" (para. [0007]). The wire coils function as a linear positional sensor that detects the longitudinal position of the target (and thus the shaft/sensor arm) to determine reservoir volume.
Based on the above teachings, it would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Burke and Miesel for the same reasons as stated for Claim 1. Both references address implantable drug delivery devices. Incorporating the volume sensor of Miesel into the pump of Burke would have provided a means to monitor reservoir volume, which is a known and critical need for patient safety and effective therapy management. The combination would have been a predictable use of prior art elements according to their established functions.
In relation to claim 16, Burke discloses a device configured to deliver fluids at a substantially constant flow rate. Burke states: "[c]onversion of the propellant fluid from a liquid phase to a gas phase increases the volume displaced by the bellows in the interior region of the housing, thereby exerting a force on a fluid external to the bellows in the housing so as to provide a substantially constant flow rate of the fluid through the fluid exit flow path" (Col. 2, lines 3-9). The constant pressure provided by the phase-change propellant system ensures a fixed, constant flow rate through the flow restrictor and catheter. Since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
In relation to claim 19, in the configuration of Claim 15, where the bellows forms the reservoir (rather than the space outside the bellows), the volume relationships are inverted from Claim 1. When the bellows is fully expanded, the reservoir volume is at maximum (full), and when the bellows is fully compressed, the reservoir volume is at minimum (empty). Miesel's sensor assembly, as applied to Claim 15, would detect the compression state of the bellows by tracking the longitudinal position of the shaft attached to the bellows wall. The circuitry would generate information correlating the bellows position with reservoir volume (para. [0025-0026]). This detection capability would be an obvious and predictable result of combining Burke and Miesel.
In relation to claim 25, Burke discloses "a pierceable, self-sealing septum disposed in the recharging fluid flow path" (Col. 3, lines 51-52). This septum is in fluid communication with the reservoir to allow refilling of the infusate. Since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Burke et al. (US 6,764,472; hereinafter “Burke”) in view of Miesel (US 2007/0255259A1), as discussed above, and in further view of Nat (US 2006/0129138A1).
In relation to claim 17, Burke discloses "at least one of a flow restrictor and a filter disposed
along the fluid exit flow path" (col. 3, lines 56-57). This flow restrictor provides restrictive flow control from the reservoir to the catheter. Nat discloses a microfabricated flow channel as applied to Claim 3 above (Abstract). Therefore, it would have been obvious to implement the flow restrictor of Burke using microfabrication techniques as taught by Nat for the same reasons as stated for Claim 3. Microfabrication provides precise flow control and device miniaturization, which are predictable benefits in implantable medical devices.
In relation to claim 18, Burke explicitly discloses that the variable volume chamber (which contains the propellant/inert gas) "may be in the form of a rigid-walled expandable bellows structure or a non-stretchable flexible bag" (Abstract). A flexible bag is a form of bladder. Burke further discloses
that “[p]referred materials for the bellows chamber include metals and plastics” (Col. 8, 11-12).
Nat further teaches the use of elastomeric materials in drug delivery devices, as discussed
for Claim 5, paragraph [0011]. Accordingly, since this enhancement was well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Burke et al. (US 6,764,472; hereinafter “Burke”) in view of Miesel (US 2007/0255259A1), as discussed above, and in further view of Stevenson (US 2006/0212096A1).
In relation to claim 22, Stevenson discloses a data information storage medium (RFID tag) and transcutaneous data retrieval using an external transponder (interrogator) as applied to Claim 8 above. It would have been obvious to incorporate the RFID system of Stevenson into the pump of Burke/Miesel for the same reasons as stated for Claim 8.
In relation to claim 23, Stevenson discloses an RFID chip containing data information related to implantable device status as applied to Claim 9 above. Since this enhancement was well-known in the art at the time of filing, its use or implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Burke et al. (US 6,764,472; hereinafter “Burke”) in view of Miesel (US 2007/0255259A1), as discussed above, and in further view of Silverman (US 6,221,056).
In relation to claim 26, while Burke does not explicitly describe a raised rim, the use of raised rims around puncturable septa would have been considered a modification of the shape of a well-known structure. Moreover, Silverman discloses in column 12, line 28, a raised rim, demonstrating the conventionality of this shape modification of a septum. Accordingly, since this enhancement was well-known in the art at the time of filing, its implementation in the invention would have been considered an obvious alternative in the design of the drug delivery device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783