CTNF 18/643,658 CTNF 70292 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 6, 16, and 19 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 . Claims 6 and 16 are rejected under 35 U.S.C. § 112(b) for lacking antecedent basis. Claim 6 recites “the therapy dosing program comprises a first proposed therapy dosing program ,” but later recites determining whether to “apply the first proposed therapy dosage program .” Claim 16 contains the same inconsistency, reciting “the therapy dosing program comprises a first proposed therapy dosing program ,” but later reciting “apply the first proposed therapy dosage program. ” Because the claims use “therapy dosing program” and “therapy dosage program” for what appears to be the same element, the scope of the claims is unclear. Applicant should amend “therapy dosage program” to “therapy dosing program,” or otherwise clarify whether a different “dosage program” is intended. Claim 19 is rejected under 35 U.S.C. § 112(b) for lacking antecedent basis. Claim 19 recites “wherein adjusting the therapy dosing program comprises adjusting the therapy dosing program are based on the instructions.” The phrase “comprises adjusting the therapy dosing program are based on the instructions” is grammatically defective and renders the metes and bounds unclear because it is not apparent whether the claim requires the act of adjusting to be based on the instructions, the program to be based on the instructions, or both. Applicant should amend the claim, for example, to recite that “adjusting the therapy dosing program comprises adjusting the therapy dosing program based on the instructions,” if that is the intended scope. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-fti The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. 07-21-fti Claim s 1-3, 6-10, 11-13, and 16-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jasperson et al. (US 2004/0181204A1; hereinafter “Jasperson”) in view of Howard et al. (US 2007/0213598A1; hereinafter “Howard”) and Villegas et al. (US 2009/0043290A1; hereinafter “Villegas”) . In relation to independent claims 1 and 11 , claim 1 recites a system comprising processing circuitry configured to determine a therapy dosing program of a medical fluid delivery device, compare a total dosage of the therapeutic fluid agent proposed for delivery during a window of time to a reference dosage defining a range with an upper limit and a lower limit, and generate output information based on the comparison; claim 11 recites the corresponding method steps. A system comprising processing circuitry / determining, by processing circuitry of a system. Jasperson discloses a programmable infusion system with controller functionality, stating that “[m]emory unit 26 and programmer 20, operating together, function as a controller 32 controlling drug delivery module 30 in the delivery of fluid medication to patient 10.” (Jasperson ¶ [0024].) Villegas further discloses programmer processing circuitry, stating that “the programmer 100a includes... a controller 138, such as a microprocessor, microcontroller or other control circuitry, memory 139... and a display 148.” (Villegas ¶ [0032].) Determine a therapy dosing program of a medical fluid delivery device / the medical fluid delivery device being configured to deliver a therapeutic fluid agent to a patient according to the therapy dosing program. Jasperson discloses a programmable drug-infusion device and a dosing regimen, stating that “Drug infusion device 14 is programmable through a telemetry link from programmer 20” and that the device may be “a pump for infusing fluid medication into a patient’s body.” (Jasperson ¶ [0023].) Jasperson further states that “[p]rogramming information, once stored in memory unit 26, provides the dosing regimen to be performed by drug delivery module 30.” (Jasperson ¶ [0025].) Hartlaub confirms therapy-program control of therapeutic-drug delivery, stating that “[i]mplanted infusion pumps deliver therapeutic drugs to a patient according to a computer program executed by a processor that is programmed with drug dosing parameters.” (Hartlaub ¶ [0003].) Compare a total dosage of the therapeutic fluid agent proposed for delivery to the patient during a window of time as defined by the therapy dosing program. Jasperson discloses computing a total dosage to be delivered over a period of time, stating that “[a] total dose of the fluid medication to be delivered to the patient over the period of time based on the basal rate and the interval rate for each of the plurality of time slots is determined.” (Jasperson ¶ [0011].) Jasperson also states that “controller 34 calculates the total daily dose provided by the programmed Steps... and compares that total dose against a maximum dose.” (Jasperson ¶ [0044].) To the extent “window of time” is broader than a daily period, Jasperson states that “[i]nstead of a daily dose, calculations could be based upon a hourly dose, a weekly dose or any other desired period of time.” (Jasperson ¶ [0050].) To a reference dosage defining a range with an upper limit and a lower limit. Jasperson discloses comparison to a maximum or preferred dose, stating that the total dose is compared “against a maximum dose, such as the maximum daily dose for patient 10 or a preferred total daily dose for patient 10 specified by the medical professional.” (Jasperson ¶ [0044].) Jasperson does not expressly disclose, in the same comparison passage, that the reference dosage is a range with both an upper limit and a lower limit. Hartlaub fills this gap by disclosing storage of upper and lower limits, stating that memory stores “base rate drug flows, the maximum and minimum daily allowable doses, patient activation requests, and drug delivery monitoring data.” (Hartlaub ¶ [0037].) Hartlaub further states that “pump manufacturers might specify certain maximum and minimum dosages for certain disorders by pre-programming their own infusion pumps with the drug dosage limitations.” (Hartlaub ¶ [0007].) Generate for output information based on the comparison. Jasperson discloses output of the calculated adjustment information, stating that “[t]he resulting calculated basal rate could be implemented or, alternatively, could be communicated, e.g., displayed, to the medical professional via programmer 20 for confirmation or adjustment by the medical professional.” (Jasperson ¶ [0046].) Hartlaub discloses comparison-based output information, stating that “[p]atient notification, for example through an alarm, may be utilized if the actual dosage would fall above or below the programmed dosage limits.” (Hartlaub ¶ [0010].) Villegas discloses a display-based warning, stating that “the programmer 100a generates a warning indicating this” and that “the warning can be generated using one or more of the LED(s) 146, alarm 147, and display 148.” (Villegas ¶ [0040].) Primary-reference gap and secondary-reference gap filling [in summary]. Jasperson discloses the proposed-program total-dose comparison and adjustment framework but does not expressly disclose the claimed reference dosage as a range having both an upper and lower limit. Hartlaub fills this gap with “maximum and minimum daily allowable doses” and manufacturer-programmed “maximum and minimum dosages.” (Hartlaub ¶¶ [0037], [0007].) Jasperson also discloses display to the medical professional, but Villegas supplies additional programmer-warning and display-confirmation details by disclosing warnings generated using “display 148.” (Villegas ¶ [0040].) Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Jasperson’s programmable infusion dosing calculation with Hartlaub’s maximum/minimum dosage-limit range and Villegas’s programmer warning/display functionality because the references address the same safety problem in programmable infusion systems . Jasperson states that “the amount of the drug typically must be limited to a maximum amount... in order not to avoid potentially damaging side effects.” (Jasperson ¶ [0026].) Hartlaub states that “frequent changing of dosage rates can lead to potential underdosing or overdosing situations.” (Hartlaub ¶ [0004].) Villegas states that it would be useful for a programmer “to check a specified delivery rate to verify that it is within a safe limit.” (Villegas ¶ [0005].) A person of ordinary skill would have combined these teachings to reduce overdose and underdose risk while providing comparison-based information to the clinician or patient. In relation to claims 2 and 12 , claim 2 depends from claim 1 and recites that the processing circuitry receives the therapy dosing program from the medical fluid delivery device. Claim 12 depends from claim 11 and recites the corresponding method limitation . Base rejection incorporated. The rejection of claims 1 and 11 is incorporated into this rejection. Receiving the therapy dosing program from the medical fluid delivery device. Villegas discloses bidirectional communication with an implantable medical device, stating that “the communication device 320 is configured to receive signals from, and transmit signals to, the programmer 100a.” (Villegas ¶ [0035].) Villegas further discloses receiving device information and programmer inputs, stating that “ambulatory medical device (e.g., IDP) information and programmer user input(s) are received and processed by the controller 138.” (Villegas ¶ [0040].) Villegas also discloses a pump-reading operation, stating that “the graphical user interface 1100 also includes a Read Pump button 1108, a Write Pump button 1110, and a Stop Pump button 1112.” (Villegas ¶ [0044].) Based on the above comments, for an artisan skilled in the art, it would have been obvious to add Villegas’s read-pump and bidirectional-communication functionality to the base Jasperson/Hartlaub system because Jasperson uses telemetry programming, stating that “[m]emory 26 receives programming information, via telemetry, from programmer 20 .” (Jasperson ¶ [0025].) Receiving the existing program from the pump before evaluating or changing it would have been a predictable safety step to ensure that the comparison is based on the actual current therapy information. In relation to claims 3 and 13 , claim 3 depends from claim 1 and recites a display configured to present an indicator indicative of the comparison. Claim 13 depends from claim 11 and recites the corresponding method limitation. Base rejection incorporated. The rejection of claims 1 and 11 is incorporated into this rejection. Display presents an indicator indicative of the comparison. Jasperson discloses displaying comparison-based adjustment information, stating that “[t]he resulting calculated basal rate could be implemented or, alternatively, could be communicated, e.g., displayed, to the medical professional via programmer 20 for confirmation or adjustment by the medical professional.” (Jasperson ¶ [0046].) Hartlaub discloses an indicator for underdose warning, stating that “[t]he warning could be an audio alarm from the pump or an indicator on the patient's controller to which the patient could respond by increasing the dosage.” (Hartlaub ¶ [0012].) Villegas discloses a display warning, stating that “the programmer 100a generates a warning indicating this” and that “the warning can be generated using one or more of the LED(s) 146, alarm 147, and display 148.” (Villegas ¶ [0040].) Based on the above teachings, for an artisan skilled in the art, it would have been obvious to present an indicator on a display because the references expressly use displays for programmer and patient safety feedback. Villegas states that the programmer includes “a display 148” and “a graphical user interface (GUI), at the display 148.” (Villegas ¶¶ [0032], [0039].) A display indicator would predictably inform a clinician or patient of the same comparison result generated by the dose-checking logic. In relation to claims 6 and 16 , claim 6 depends from claim 1 and recites determining, based on generated information, whether to apply the first proposed therapy dosage program, adjust it, or replace it with a second proposed therapy dosing program. Claim 16 depends from claim 11 and recites the corresponding method limitation. Base rejection incorporated. The rejection of claims 1 and 11 is incorporated into this rejection. Apply the proposed therapy program. Villegas discloses accepting a requested protocol when approved, stating that “[i]f the result of this determination is affirmative, the user of the programmer 100a, at 606, is prompted to provide an additional input or verification of the requested drug delivery protocol.” (Villegas ¶ [0040].) Villegas also discloses a write-confirmation pathway, stating that “the programmer generates a confirmation window which displays the data that is to be written to the IDP.” (Villegas ¶ [0053].) Adjust the proposed therapy program. Jasperson discloses adjustment based on the calculated comparison, stating that “[i]f the total amount of drug to be delivered exceeds the maximum dose, controller 32 adjusts the basal rate so that the total dose to be delivered to patient 10 does not exceed that maximum dose.” (Jasperson ¶ [0044].) Hartlaub discloses prompting base-rate changes, stating that “the patient would be prompted... to use the patient controller to select the next lowest base rate to reduce drug usage.” (Hartlaub ¶ [0039].) Replace the first proposed therapy dosing program with a second proposed therapy dosing program. Villegas discloses clearing or resetting an unacceptable parameter display, stating that “[i]f the user answer is ‘No’, at 838, the parameter display is cleared or reset.” (Villegas ¶ [0059].) Villegas further discloses that “the programmer is adapted to deny a requested drug delivery protocol that is not clinician-approved” and “limit a requested drug delivery protocol... to conform with the clinician-approved drug delivery protocol.” (Villegas ¶ [0066].) Under the broadest reasonable interpretation, clearing/resetting, denying, or limiting a requested protocol to conform to an approved protocol teaches replacing the unacceptable proposed program with a different acceptable program. Based on the above teachings, for an artisan skilled in the art, it would have been obvious to determine whether to apply, adjust, or replace a proposed therapy dosing program because Jasperson calculates and adjusts a basal rate based on maximum-dose comparison , Hartlaub prompts up/down base-rate changes based on underdose/overdose conditions , and Villegas accepts, verifies, limits, denies, or resets requested protocols . The references all pursue the same safety objective of preventing harmful or uncomfortable therapy. Villegas states that safety features “limit the possibility that a clinician would program a harmful or uncomfortable therapeutic regimen.” (Villegas ¶ [0005].) In relation to claims 7 and 17 , claim 7 depends from claim 1 and recites that the therapy dosing program includes a therapy schedule defining a rate and a duration for delivery. Claim 17 depends from claim 11 and recites the corresponding method limitation. Base rejection incorporated. The rejection of claims 1 and 11 is incorporated into this rejection. Therapy schedule defining a rate and a duration. Jasperson discloses a schedule of time slots and delivery rates, stating that fluid medication is delivered “continually at a basal rate and capable of delivering the fluid medication at an interval rate in each of a plurality of time slots over a specified period of time.” (Jasperson ¶ [0011].) Jasperson further states that a programmed regimen includes time slots, for example “Time Slot,” “Time of Day,” “Delivery Rate,” and “Drug Delivered.” (Jasperson ¶ [0029].) Jasperson describes “a total delivery rate of 35 milligrams per hour for a three hour time period.” (Jasperson ¶ [0052].) Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use Jasperson’s rate-and-duration schedule in the base system because Jasperson’s total-dose comparison depends on rates over time slots , and Hartlaub’s therapy program similarly stores “base rate drug flows” and “maximum and minimum daily allowable doses .” (Hartlaub ¶ [0037].) A schedule defining both rate and duration is the predictable input needed to compute total dosage over the claimed window of time. In relation to claims 8 and 18 , claim 8 depends from claim 1 and recites adjusting the therapy dosing program. Claim 18 depends from claim 11 and recites the corresponding method step. Base rejection incorporated. The rejection of claims 1 and 11 is incorporated into this rejection. Adjust the therapy dosing program. Jasperson discloses adjustment of the basal rate, stating that “[i]f the total amount of drug to be delivered exceeds the maximum dose, controller 32 adjusts the basal rate so that the total dose to be delivered to patient 10 does not exceed that maximum dose.” (Jasperson ¶ [0044].) Jasperson also discloses adjustment when a preferred dose is exceeded or not reached, stating that “if the specified basal rate... and the specified interval rates... either exceed or fall under the preferred daily dose, drug infusion system 12 may calculate a new basal rate.” (Jasperson ¶ [0049].) Hartlaub discloses a therapy program for “possible drug infusion rate adjustments.” (Hartlaub ¶ [0037].) Based on the above teachings, for an artisan skilled in the art, it would have been obvious to adjust the therapy dosing program in response to comparison output because adjustment is the direct safety action taught by Jasperson and Hartlaub . Jasperson adjusts the basal rate to maintain maximum or preferred dosage, and Hartlaub states that the therapy program steps “allow the patient to adjust the therapy to provide a more efficient and effective drug treatment.” (Hartlaub ¶ [0038].) In relation to claims 9 and 19 , claim 9 depends from claim 8 and recites that the output information comprises instructions to adjust the therapy dosing program and that the processing circuitry adjusts based on the instructions. Claim 19 depends from claim 18 and recites a corresponding method limitation. Base rejection incorporated. The rejection of claims 8 and 18 is incorporated into this rejection. Output information comprises instructions to adjust the therapy dosing program. Jasperson discloses communicating adjustment information for confirmation or adjustment, stating that “[t]he resulting calculated basal rate could be implemented or, alternatively, could be communicated, e.g., displayed, to the medical professional via programmer 20 for confirmation or adjustment by the medical professional.” (Jasperson ¶ [0046].) Hartlaub discloses prompts that instruct adjustment, stating that “the therapy program may prompt the patient... to either activate a bolus dose of medication or to use the next highest base rate.” (Hartlaub ¶ [0040].) Hartlaub also discloses prompting a lower base rate, stating that “the patient would be prompted... to use the patient controller to Select the next lowest base rate to reduce drug usage.” (Hartlaub ¶ [0039].) Processing circuitry adjusts based on the instructions. Villegas discloses verification and writing of new programming data, stating that “the programmer generates a confirmation window which displays the data that is to be written to the IDP.” (Villegas ¶ [0053].) Villegas further states that the Write Confirmation Display indicates “both the previous and new programming values/information” and that “all programming changes are highlighted.” (Villegas ¶ [0054].) Based on the above teachings, for an artisan skilled in the art, it would have been obvious to implement adjustment based on output instructions because the references disclose displaying calculated changes, prompting the user to make base-rate changes, and writing new programming data to the pump . Combining these teachings predictably provides a clinician-confirmed, safety-oriented workflow for changing a therapy dosing program after a comparison indicates overdose or underdose risk. In relation to claim 10 , claim 10 depends from claim 9 and recites receiving the instructions from a clinician programmer based on clinician input. Base rejection incorporated. The rejection of claim 9 is incorporated into this rejection. Receiving instructions from a clinician programmer based on clinician input. Jasperson discloses clinician programming through an external programmer, stating that “Drug infusion device 14 is programmable through a telemetry link from programmer 20” and that the programming is performed under direction of a medical professional. (Jasperson ¶¶ [0023], [0010].) Villegas discloses a clinician programmer, stating that the system includes “a clinician programmer 100b (such as a clinician programmer/field Support system)” that “facilitates RF communications between the clinician programmer 100b and the implantable medical device 300.” (Villegas ¶ [0031].) Villegas further discloses clinician input, stating that if “the clinician specifies a dosage that is greater than the standard maximum dosage,” the programmer alerts the clinician and prompts whether it is acceptable. (Villegas ¶ [0041].) Based on the above teachings, for an artisan skilled in the art, it would have been obvious to receive the adjustment instructions from a clinician programmer because Jasperson’s system is expressly programmed under the direction of a medical professional and Villegas provides a clinician programmer that communicates with the implantable device . Such a combination would have improved patient safety by ensuring that dosage-program changes are approved through clinician input . 07-21-fti Claim s 4, 5, 14, 15, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jasperson et al. (US 2004/0181204A1; hereinafter “Jasperson”) in view of Howard et al. (US 2007/0213598A1; hereinafter “Howard”) and Villegas et al. (US 2009/0043290A1; hereinafter “Villegas”), as discussed above, and in further view of Howard et al. (US 2007/0213598A1; hereinafter “Howard”) . In relation to claims 4 and 14 , claim 4 depends from claim 1 and recites determining that the total dosage is outside the range defined by the reference dosage. Claim 14 depends from claim 11 and recites the corresponding method limitation . Base rejection incorporated. The rejection of claims 1 and 11 is incorporated into this rejection. Determining that the total dosage is outside the range. Hartlaub discloses above/below dosage-limit detection, stating that “[p]atient notification, for example through an alarm, may be utilized if the actual dosage would fall above or below the programmed dosage limits.” (Hartlaub ¶ [0010].) Howard discloses range validation, stating that “[o]ne form of validation is range checking to restrict out of range values from being transmitted.” (Howard ¶ [0056].) Howard also discloses that rule-set constraints (RSC) “verify that entries are within valid ranges.” (Howard ¶ [0074].) Based on the above teachings, for an artisan skilled in the art, it would have been obvious to determine whether the calculated total dosage is outside the Hartlaub/Howard range because Jasperson already compares total dose against a maximum dose and adjusts if the maximum is exceeded . Jasperson states that “[i]f the total amount of drug to be delivered exceeds the maximum dose, controller 32 adjusts the basal rate.” (Jasperson ¶ [0044].) Extending that comparison to both above-limit and below-limit determinations would have predictably reduced both overdose and underdose risk. In relation to claims 5 and 15 , claim 5 depends from claim 1 and recites that the reference dosage comprises a non-patient-specific reference dosage. Claim 15 depends from claim 11 and recites the corresponding method limitation . Base rejection incorporated. The rejection of claims 1 and 11 is incorporated into this rejection. Non-patient-specific reference dosage. Hartlaub discloses manufacturer-defined, disorder-specific limits, stating that “pump manufacturers might specify certain maximum and minimum dosages for certain disorders by pre-programming their own infusion pumps with the drug dosage limitations.” (Hartlaub ¶ 0056 [0007].) Villegas discloses clinic-level limits, stating that systems generate warnings or limitations by “tracking usage per clinic or per patient” and that it is possible to limit delivery “in response to the maximum rate previously used for the specified drug either within the clinic as a whole or for the specific patient being treated.” (Villegas ¶ [0056].) Howard discloses non-patient-specific clinical-care-area limits, stating that “[t]he same drug may have different limits established in different clinical care areas.” (Howard ¶ [0005].) Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use non-patient-specific limits in the base dose-comparison system because Hartlaub, Villegas, and Howard disclose manufacturer, clinic, and clinical-care-area limits that are not limited to a single patient. A person of ordinary skill would have used such limits to provide default safety ranges before individualized adjustment, particularly because Howard states that downloaded information can include “a drug library with one or more drug entries typically grouped by clinical care area” and “drug delivery parameters (such as hard and soft limits).” (Howard ¶ [0006].) In relation to independent claim 20 , claim 20 recites a non-transitory computer-readable medium storing instructions that, when executed, cause processing circuitry to perform the functions recited in substance in claim 1. Base rejection incorporated. The rejection of claim 1 is incorporated. Jasperson, Hartlaub, and Villegas disclose the determining, comparing, and generating limitations as discussed above. Non-transitory computer-readable medium storing instructions. Jasperson discloses stored programming information, stating that “[p]rogramming information, once stored in memory unit 26, provides the dosing regimen to be performed by drug delivery module 30.” (Jasperson ¶ [0025].) Hartlaub discloses stored program instructions, stating that “[t]he central processor unit 108 controls the amount of drug treatment administered to the patient according to the therapy program instructions stored in a program memory 110.” (Hartlaub ¶ [0024].) To the extent Jasperson and Hartlaub do not expressly recite a “computer-readable medium,” Howard fills the gap by disclosing “a system that utilizes a remote computer and a software program on a computer readable medium to download information to and/or upload information from one or more infusion pumps.” (Howard ¶ [0004].) Based on the above teachings, for an artisan skilled in the art, it would have been obvious to implement the Jasperson/Hartlaub/Villegas programmable dosing and warning functions as instructions on a non-transitory computer-readable medium because Howard teaches the same infusion-pump programming field and expressly uses “a software program on a computer readable medium” for communication with infusion pumps . (Howard ¶ [0004].) Therefore, for an artisan skilled in the art, the predictable result would have been a stored software implementation of the same dose-checking and programmer-display functions. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Respectfully submitted, /MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783 Application/Control Number: 18/643,658 Page 2 Art Unit: 3783 Application/Control Number: 18/643,658 Page 3 Art Unit: 3783 Application/Control Number: 18/643,658 Page 5 Art Unit: 3783 Application/Control Number: 18/643,658 Page 6 Art Unit: 3783 Application/Control Number: 18/643,658 Page 8 Art Unit: 3783 Application/Control Number: 18/643,658 Page 9 Art Unit: 3783 Application/Control Number: 18/643,658 Page 10 Art Unit: 3783 Application/Control Number: 18/643,658 Page 11 Art Unit: 3783 Application/Control Number: 18/643,658 Page 12 Art Unit: 3783
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