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. Election/Restrictions Restriction to one of the following inventions is required under 35 U.S.C. 121: I. Claims 1-12, drawn to a vibrating anesthesia device, classified in A61M5/42. II. Claims 13-20, drawn to a method for reducing pain during a medical procedure, classified in A61M5/422. The inventions are independent or distinct, each from the other because: Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case t he process as claimed can be practiced with another materially different product such as a handheld device which is held against the skin proximate the procedure site, rather than a device which require s a t least one finger cuff that is fit onto a finger of the user . Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: T he inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries) and art applicable to one invention may not be applicable to the other . Applicant is advised that the reply to this requirement to be complete must include ( i ) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention . The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. During a telephone conversation with Attorney of Record Rodney Fuller on March 12, 2026 a provisional election was made without traverse to prosecute the invention of Group I , claim s 1-12 . Affirmation of this election must be made by applicant in replying to this Office action. Claim s 13-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01. Information Disclosure Statement The information disclosure statement (IDS) submitted on July 31, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim s 1-2 and 6-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gupta et al. (WO 2023181055), hereinafter Gupta. Regarding claim 1, Gupta discloses a vibrating anesthesia device (device of Fig. 1) , comprising: at least two flexible finger cuffs (Fig. 1 and [019-020; 030; 032], cuffs 201 and 202 which are configured to fit onto phalanges of a finger, therefore must be flexible to fit various finger sizes) each configured to fit onto a finger of a user ([032], cuffs 201 and 202 are configured to fit onto a phalanx of a finger), each of the at least two finger cuffs having a vibrator motor (Fig. 1b and [035], cuff 201 comprises stimulant 203 and cuff 202 comprises stimulant 204, stimulants are vibratory motors) configured to be positioned adjacent a fingertip of the user when the finger cuff is positioned on the finger of the user (Fig. 1b and [030; 037], stimulants 203 and 204 are positioned at the distal phalanx (tip) of the fingers), wherein a first finger cuff of the at least two finger cuffs is sized and shaped to fit on an index finger of the user ([037], finger cuff 201 is shaped to fit on the index finger) and a second finger cuff of the at least two finger cuffs is sized and shaped to fit on a thumb of the user ([037], finger cuff 202 is shaped to fit on the thumb) ; a pressure switch positioned within the first finger cuff (Fig. 1b, pressure switch 205 on cuff 201), wherein the pressure switch is configured to sense a force exerted on the pressure switch ([024], pressure switch 205 senses a pressure force applied to the phalanx/finger cuff); and a control unit configured to attach to a wrist of the user (Fig. 1-2, control unit attached to wrist via attachment means 102) , the control unit having a power source (Fig. 2, power source 103), a controller (Fig. 2, controller 103), and an interface configured to allow the user to control the vibrating anesthesia device (Fig. 1-3, [045], casing module 101 which holds the other components of the control unit, and comprises a pressure sensor 503 which the surgeon may activate, thus turning on the controller. Therefore, the surgeon/user is able to control the device), wherein the control unit is electrically coupled to the pressure switch and to each of the vibrator motors (Figs. 1-2 and [037-038], control unit is electrically coupled to the stimulants 203/204 and the pressure switch 205) and wherein the control unit is configured to provide power to the pressure switch, monitor the force exerted on the pressure switch, and turn on each of the vibrator motors of the at least two finger cuffs when the force exerted on the pressure switch exceeds a threshold value (F i g. 3 and [032, 045], control unit provides power to the components of the device, such as the pressure switch 205, wherein the control unit monitors the pressure applied pressure, and when the pressure applied exceeds a threshold value, the pressure signal is detected within the control unit, causing the microcontroller of the unit to turn on/toggle each of the vibration motors of stimulants 203/204) ; wherein, when turned on, the vibrator motors are configured to vibrate and provide a local anesthetic effect to a patient ([039-040], when turned on the stimulants 203/204 vibrate and provide an anesthetic effect to the local area) . Regarding claim 2, Gupta discloses the vibrating anesthesia device of claim 1, further comprising a glove configured to fit over a hand of the user and create a barrier between the vibrating anesthesia device and the patient ([034, 047], device may be configured as a hand glove, made with electrically insulating fabric, therefore creating a barrier between the patient and at least a portion of the device) , wherein an index finger of the glove is sized to fit the first finger cuff and the index finger of the user, and a thumb of the glove is sized to fit the second finger cuff and the thumb of the user ([034, 037, 047], with device configure to be hand worn as a hand glove, the hand glove must be configured to fit the cuffs with stimulants 203/204 on the index finger and thumb, respectively, in order to allow vibration to be applied to these phalanges and induce the anesthetic effect). Regarding claim 6, Gupta discloses a vibrating anesthesia device (device of Fig. 1) , comprising: a first finger cuff (Fig. 1, cuff 201) configured to fit onto a finger of a user (Fig. 1 and [019-020; 030; 032], cuff 201 is configured to fit onto phalanx of a finger) , the first finger cuff having a vibrator motor (Fig. 1b and [035], cuff 201 comprises stimulant 203, which is a vibratory motor) configured to be positioned adjacent a fingertip of the user when the finger cuff is positioned on the finger of the user (Fig. 1b and [030; 037], stimulant 203 is positioned at the distal phalanx (tip) of the finger) ; a pressure switch positioned within the first finger cuff (Fig. 1b, pressure switch 205 on cuff 201) , wherein the pressure switch is configured to sense a force exerted on the pressure switch ([024], pressure switch 205 senses a pressure force applied to the phalanx/finger cuff) ; and a control unit configured to attach to a wrist of the user (Fig. 1-2, control unit attached to wrist via attachment means 102) , wherein the control unit is electrically coupled to the pressure switch and to the vibrator motor (Figs. 1-2 and [037-038], control unit is electrically coupled to the stimulants 203/204 and the pressure switch 205) and wherein the control unit is configured to provide power to the pressure switch, monitor the force exerted on the pressure switch, and turn on the vibrator motor when the force exerted on the pressure switch exceeds a threshold value (Fig. 3 and [032, 045], control unit provides power to the components of the device, such as the pressure switch 205, wherein the control unit monitors the pressure applied pressure, and when the pressure applied exceeds a threshold value, the pressure signal is detected within the control unit, causing the microcontroller of the unit to turn on/toggle the vibration motors of stimulant 203) ; wherein, when turned on, the vibrator motor is configured to vibrate and provide a local anesthetic effect to a patient ([039-040], when turned on the stimulant 203 vibrates and provides an anesthetic effect to the local area) . Regarding claim 7, Gupta discloses the vibrating anesthesia device of claim 6, further comprising a second finger cuff (Fig. 1, cuff 202) configured to fit onto a second finger of the user (Fig. 1 and [019-020; 030; 032], cuff 202 is configured to fit onto phalanx of a finger) , the second finger cuff having a vibrator motor (Fig. 1b and [035], cuff 202 comprises stimulant 204, which is a vibratory motor) , wherein the control unit is configured to turn on the vibrator motor of the second finger cuff with the vibrator motor of the first finger cuff (Fig. 3 and [032, 045], control unit provides power to the components of the device and has a microcontroller which is configured to turn on/toggle the vibration motors of stimulants 203/204 together) . Regarding claim 8, Gupta discloses the vibrating anesthesia device of claim 7, wherein the first finger cuff is sized and shaped to fit on an index finger of the user ([037], finger cuff 201 is shaped to fit on the index finger) and the second finger cuff is sized and shaped to fit on a thumb of the user ([037], finger cuff 202 is shaped to fit on the thumb) . Regarding claim 9, Gupta discloses the vibrating anesthesia device of claim 7, further comprising a glove configured to fit over a hand of the user and create a barrier between the vibrating anesthesia device and the patient ([034, 047], device may be configured as a hand glove, made with electrically insulating fabric, therefore creating a barrier between the patient and at least a portion of the device) , wherein an index finger of the glove is sized to fit the first finger cuff and the index finger of the user, and a thumb of the glove is sized to fit the second finger cuff and the thumb of the user ([034, 037, 047], with device configure to be hand worn as a hand glove, the hand glove must be configured to fit the cuffs with stimulants 203/204 on the index finger and thumb, respectively, in order to allow vibration to be applied to these phalanges and induce the anesthetic effect). Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim s 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta (WO 2023181055) in view of Gulley et al. (US 20220331548), hereinafter Gulley . Regarding claim 3, Gupta discloses the vibrating anesthesia device of claim 1. Gupta fails to disclose wherein the control unit is configured to turn on each of the vibrator motors only after the force exerted on the pressure switch exceeds the threshold value for at least two seconds. However, Gulley discloses wherein the control unit is configured to turn on each of the vibrator motors only after the force exerted on the pressure switch exceeds the threshold value for at least two seconds ([0236-0240], an alarm state/triggering of a device component (similar to the turn on/toggle each of the vibration motors of Gupta) may be generated if a measured parameter (pressure sensed in device of Gupta) exceeds a threshold value for a defined period of time. Such as more than 2 seconds) . It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gupta to incorporate the disclosures of Gulley and modify the control unit to be configured to turn on each of the vibrator motors only after the force exerted on the pressure switch exceeds the threshold value for at least two seconds. Doing so would allow for continuous assessment of the parameter, ensuring maintained a n exceeded threshold value for a period of time before triggering of downstream event, thus ensuring the conditions were fully met, and therefore not accidental (Gulley, [0236-0240]). Regarding claim 10 , Gupta discloses the vibrating anesthesia device of claim 6 . Gupta fails to disclose wherein the control unit is configured to turn on the vibrator motor only after the force exerted on the pressure switch exceeds the threshold value for at least two seconds. However, Gulley discloses wherein the control unit is configured to turn on the vibrator moto r only after the force exerted on the pressure switch exceeds the threshold value for at least two seconds ([0236-0240], an alarm state/triggering of a device component (similar to the turn on/toggle the vibration motor of Gupta) may be generated if a measured parameter (pressure sensed in device of Gupta) exceeds a threshold value for a defined period of time. Such as more than 2 seconds) . It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gupta to incorporate the disclosures of Gulley and modify the control unit to be configured to turn on the vibrator motor only after the force exerted on the pressure switch exceeds the threshold value for at least two seconds. Doing so would allow for continuous assessment of the parameter, ensuring maintained a n exceeded threshold value for a period of time before triggering of downstream event, thus ensuring the conditions were fully met, and therefore not accidental (Gulley, [0236-0240]). Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta (WO 2023181055) in view of Baxter et al. (WO 2020047175) , hereinafter Baxter. Regarding claim 4, Gupta discloses the vibrating anesthesia device of claim 1. Gupta fails to disclose wherein the vibrator motors are configured to vibrate at a frequency between 100 Hz and 200 Hz. However, Baxter discloses wherein the vibrator motors are configured to vibrate at a frequency between 100 Hz and 200 Hz ([0089], device can provide vibrations in the range of about 180-200 Hz). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gupta to incorporate the disclosures of Baxter and modify the vibrator motors to vibrate at a frequency between 100 Hz and 200 Hz. Doing so would allow the device to provide its intended effect to the user, such as pain/irritating sensation control to localized areas (Baxter, [0009-0010; 0089]), therefore providing a local anesthetic effect to the area. Regarding claim 11 , Gupta discloses the vibrating anesthesia device of claim 6 . Gupta fails to disclose wherein the vibrator motor is configured to vibrate at a frequency between 100 Hz and 200 Hz. However, Baxter discloses wherein the vibrator motor is configured to vibrate at a frequency between 100 Hz and 200 Hz ([0089], device can provide vibrations in the range of about 180-200 Hz). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gupta to incorporate the disclosures of Baxter and modify the vibrator motor to vibrate at a frequency between 100 Hz and 200 Hz. Doing so would allow the device to provide its intended effect to the user, such as pain/irritating sensation control to localized areas (Baxter, [0009-0010; 0089]), therefore providing a local anesthetic effect to the area. Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta (WO 2023181055) in view of Decock et al. (US 20210106777) , hereinafter Decock . Regarding claim 5, Gupta discloses the vibrating anesthesia device of claim 1. Gupta fails to disclose wherein the threshold value is at least 3.5 Newtons. However, Decock discloses wherein the threshold value is at least 3.5 Newtons (Fig. 6 and [0086], a pressure threshold for triggering a device may be 7 to 10 N). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gupta to incorporate the disclosures of Decock and modify the threshold value to be at least 3.5 Newtons. Doing so would provide a threshold value that ensures that a pressure being applied to the area is sufficient enough to cause the triggering of the device, such as the pressure needed to be applied to the skin by a drug delivery device (and vice versa) prior to injection for successful and complete delivery ( Decock , [0020,0086]) . Regarding claim 12 , Gupta discloses the vibrating anesthesia device of claim 6 . Gupta fails to disclose wherein the threshold value is at least 3.5 Newtons. However, Decock discloses wherein the threshold value is at least 3.5 Newtons (Fig. 6 and [0086], a pressure threshold for triggering a device may be 7 to 10 N). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gupta to incorporate the disclosures of Decock and modify the threshold value to be at least 3.5 Newtons. Doing so would provide a threshold value that ensures that a pressure being applied to the area is sufficient enough to cause the triggering of the device, such as the pressure needed to be applied to the skin by a drug delivery device (and vice versa) prior to injection for successful and complete delivery ( Decock , [0020,0086]) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SARAH D GRASMEDER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0258 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8 am-5 pm EST . 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, FILLIN "SPE Name?" \* MERGEFORMAT BHISMA MEHTA can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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. /SARAH DYMPNA GRASMEDER/ Examiner, Art Unit 3783 /LAURA A BOUCHELLE/ Primary Examiner, Art Unit 3783