CTNF 18/613,659 CTNF 70292 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 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 1-20 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 1 recites, in relevant part, “a needle cannula defining a lumen comprising a proximal end, a distal end comprising a sharpened tip ,” and later recites “a closed distal end enclosing the distal tip of the needle cannula.” The phrase “the distal tip” lacks clear antecedent basis. The claim previously introduces “a distal end comprising a sharpened tip,” not “a distal tip.” Claim 14 depends from claim 13 and recites that, “in the retracted position, the distal segment of the first arm and/or the second arm is substantially perpendicular to a longitudinal axis of the needle guard. ” Claim 14 is rejected under § 112(b) as indefinite because “ the needle guard ” lacks antecedent basis. The claim set introduces a “ needle guard assembly, ” not a “ needle guard .” 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-aia AIA 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. 07-21-aia AIA Claim s 1-10, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (US 2016/0067410A1; hereinafter “Carr”) in view of Adriaantje et al. (NL2019483B1; hereinafter “Adriaantje”) . Independent claim 1 recites a needle guard assembly comprising a needle cannula defining a lumen and having a proximal end, a distal end with a sharpened tip, and a tubular body; a needle hub connected to the proximal end and configured to mount to a fluid delivery device to provide fluid communication; and a liquid-permeable cover member extending over at least the distal end of the needle cannula, with a proximal end engaged to the needle hub and a closed distal end enclosing the distal tip. In relation to independent claim 1 , Carr discloses the basic filtered needle assembly. Carr states that “the filtered needle including a needle and connector portion and a filtering needle cap,” (Carr, ¶ [0016]) and that the needle and connector portion includes “a hollow needle with a needle distal end having an opening to a lumen running through the hollow needle; and a hub” (Carr, ¶ [0016]). Carr further states that “the hub including an open proximal end adapted to reversibly engage a fluid fitting and; a distal end of the hub engaged with a proximal end of the hollow needle” (Carr, ¶ [0016]). Carr further discloses that “[t]he needle and connector portion 16 has a proximal end 34 which may be in the form of a hub 78,” (Carr ¶ [0053]) that the hub may work with a Luer fitting, and that “a hollow needle 36 is secured to the proximal end 34 … and extends axially within the intermediate portion 30 of the filtering needle cap 14” (Carr ¶ [0055]). Carr also discloses that the filtering cap includes a filter element for removing debris as liquid is drawn into the hollow needle (Carr ¶ [0016]). Carr does not expressly disclose that the filtering needle cap has a closed distal end enclosing the sharpened tip; rather, it teaches that “the filtering needle cap 14 has a distal portion 26 which is open ” (Carr ¶ [0052]). However, Adriaantje fills that gap by disclosing a needle filter structure having a closed distal end with perforations. Adriaantje states that a tubular shaft is “closed at its extreme distal end … by an end wall,” and that the end wall has “a perforated region … which forms a grating … for preventing surgical debris and/or retinal tissue entering the needle” (Adriaantje, page 1, lines 24-27). Adriaantje further teaches that “the extreme distal end of the needle 142 is closed by an end wall 150,” and that the end wall includes perforations that form a grating acting as a filter for debris or particles ( Adriaantje , page 3, lines 15-18). Based on the above teachings, it would have been obvious to modify Carr’s filtering needle cap to include Adriaantje’s perforated closed distal end so that the distal needle tip is enclosed while still allowing liquid to pass through the cover. The motivation is expressly tied to the same problem addressed by Carr: filtering debris from liquid before administration. Carr identifies glass-ampoule debris, explaining that glass ampoules may produce “debris in the form of glass shards” that “must be removed from the pharmaceuticals prior to administration” (Carr ¶ [0003]). Moreover, Adriaantje teaches that a perforated end-wall grating prevents debris from entering the needle and reduces blockage by allowing particles to move laterally away from the tip. (Adriaantje, page 2, lines 3-7). A person of ordinary skill would therefore have combined Carr’s filter-cap needle assembly with Adriaantje’s closed perforated end-wall structure to improve safety, maintain filtration, and enclose the sharpened needle tip while permitting liquid flow. In relation to claim 2 , this claim depends from claim 1 and further recites that the liquid-permeable cover member is configured to filter solid particles from a medical solution before the medical solution is drawn into the lumen of the needle cannula. Claim 2 is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 1. Carr expressly teaches the additional filtering function. Carr states that the filtering needle cap includes “a filter element adapted for removing debris from the liquid payload as the liquid payload is drawn through the filtering needle cap into the lumen within the hollow needle” (Carr ¶ [0016]). Carr further explains that “any debris in the receptacle of liquid payload drawn up in the pharmaceutical is trapped in the filter element” (Carr ¶ [0075]). Carr therefore discloses the solid-particle filtering function. To the extent the claim requires that the filtering function be performed through a closed, perforated cover member, Adriaantje teaches the closed perforated grating that prevents debris and particles from entering the needle (Adriaantje, page 1, lines 24-27). For and artisan skilled in the art, the motivation to combine remains the same as for claim 1: reducing glass or other solid contamination before medical administration. In relation to claim 3 , this claim depends from claim 1 and further recites that the needle cannula comprises an injection needle for subcutaneous, intramuscular, and/or intravenous injections. Claim 3 is rejected over the combination of Carr in view of Adriaantje, as discussed above with respect to claim 1. Carr teaches that the term needle includes a “hypodermic needle or analogous needle with an open distal end and an interior lumen to allow for movement of a liquid” (Carr ¶ [0002]). Carr also states that its filtered needle may be used with human patients and in applications that benefit from filtering a liquid payload before delivery (Carr ¶ [0002]). Therefore, for an artisan skilled in the art, the additional injection-needle limitation would have been obvious for a filtered hypodermic needle intended to administer pharmaceuticals to human patients. In relation to claim 4 , this claim depends from claim 1 and further recites that the cover member is substantially rigid and defines a cylindrical cavity enclosing the sharpened tip without contacting the needle cannula. Claim 4 is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 1. Carr teaches a filtering cap that surrounds the needle, including that “a hollow needle 36 … extends axially within the intermediate portion 30 of the filtering needle cap 14 towards the distal portion 26,” (Carr ¶ [0055]) and that the distal portion may have “a smooth cylindrical inner wall” (Carr ¶ [0058]). Carr also teaches that a filtering needle cap may be “formed of a rigid material” (Carr ¶ [0085]). Carr does not expressly require a closed distal cavity that avoids contacting the needle tip, but Adriaantje teaches a closed distal end and grating for a tubular structure. Therefore, for an artisan skilled in the art, it would have been obvious to provide the surrounding filter cap with a rigid cylindrical cavity and a closed perforated distal end to protect the needle tip while allowing filtered draw-up. In relation to claim 5 , this claim depends from claim 1 and further recites that the cover member comprises a plurality of perforations permitting solutions to pass through the cover member and into the lumen, with perforations comprising holes made by laser cutting or heat staking [t he phrase “holes made by laser cutting or heat staking” creates a product by process claim] . Nevertheless, Carr teaches liquid passing through a filter element and into the lumen of the needle (Carr ¶ [0016]). Carr does not disclose a closed perforated distal cover. However, Adriaantje teaches that the end wall includes a “perforated region” and that “perforations 152 are herein seen as apertures extending all the way through material of the end wall” (Adriaantje, page 3, lines 19-20). Adriaantje further teaches that “the perforations 152 can take the form of a plurality of holes (e.g. an array of holes)” and may be circular, hexagonal, or square (Adriaantje, page 3, lines 27-32). Adriaantje also teaches forming perforations in the closed distal end wall. (Adriaantje, page 3, lines 15-18). Adriaantje does not expressly state “laser cutting” or “heat staking” in the extracted text relied upon. However, Adriaantje teaches that perforations may be formed using “milling or similar cutting techniques” (Adriaantje, page 5, lines 18-23). Therefore, a person of ordinary skill in medical-device manufacture would have found it obvious to use a known precision cutting technique, such as laser cutting , to make small perforations in a medical filter cover, especially where the reference already teaches cutting perforations through an end wall. In relation to claim 6 , this claim depends from claim 5 and further recites a first plurality of holes through a sidewall of the cover member and a second plurality of holes through the closed distal end. Claim 6 is rejected over Carr in view of Adriaantje, as discussed above with respect to claims 1 and 5. Adriaantje expressly teaches perforations extending across the end wall and partly along the sidewall: “the slots may extend across the end wall 150 of the needle 140 and partway along a sidewall(s) 190 of the tubular shaft 144” (Adriaantje, page 3, lines 35-36). Adriaantje further states that in embodiments in which perforations extend partway along the sidewalls, those sidewall perforations may be formed by the same methods as the perforations in the end wall (Adriaantje, page 5, lines 18-23). Therefore, for an artisan skilled in the art, it would have been obvious to provide both distal-end and sidewall perforations in the modified Carr filtering cover to preserve flow if the front face is occluded, which is the specific benefit taught by Adriaantje. In relation to claim 7 , this claim depends from claim 1 and further recites an outer shield positioned over the cover member for protection during transportation and before use, with a proximal portion engaging the needle hub and engaging a more proximal hub surface than the cover member. Claim 7 is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 1. Carr expressly discloses an outer cap over the filtering needle cap. Carr states that “the filtered needle 10 includes an outer cap 12, a filtering needle cap 14 coaxially disposed within the outer cap 12 and a needle and connector portion 16 coaxially disposed within the filtering needle cap 14,” and that “the outer cap 12 has a closed distal end 18, a proximal portion 20 which is open and an intermediate section 22 having an inner chamber 24 … for receiving the filtering needle cap 14 therein” (Carr ¶ [0051]). Carr further teaches that the outer cap is removed before draw-up and that, in many instances, the device is delivered with the outer cap covering a portion of the filtering needle cap (Carr ¶ [0070]). Therefore, for an artisan skilled in the art, it would have been obvious for the outer cap or shield to engage a proximal hub surface to retain the cap during shipping, because Carr’s purpose is to deliver the filter needle in an assembled sterile condition. In relation to claim 8 , this depends from claim 1 and further recites a tiered cover member with a narrow distal tier and a wide proximal tier, perforations on the distal tier, a proximal tier free from perforations, and a seal positioned in the cover member with a central opening sized to receive a sidewall of the needle cannula. Claim 8 is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 1. Carr teaches a tiered or stepped cap geometry in which the filtering needle cap “has an interior channel 678 which tapers in a tapering section 686 from a first section 680 having diameter D to a second section 688 with a reduced inner diameter” (Carr ¶ [0084]). Carr also discloses sealing sleeve and annulus embodiments: “the sealing sleeve 50 has a cylindrical central opening … sized for receiving the needle 36,” and an interference fit is formed with the needle (Carr ¶ [0060]). Adriaantje supplies the perforated distal-tier feature by teaching perforations in a closed end wall (Adriaantje; figure 2) and, optionally, sidewall perforations at the distal end (Adriaantje, page 4, lines 19-24). Therefore, a person of ordinary skill would have placed the perforations on the distal tier to expose the filtering region to the source liquid while leaving the proximal sealing tier unperforated to preserve suction. In relation to claim 9 , this claim depends from claim 8 and further recites that the seal is seated at an intersection between the proximal and distal tiers and allows creation of suction in a space defined by the seal and the cover member during aspiration. Claim 9 is rejected over Carr in view of Adriaantje, as discussed above with respect to claims 1 and 8. Carr teaches that a seal is formed between the needle and the cap, and that “the suction force for drawing up the liquid payload is confined to the pathway by the sealing sleeve 50 which closes the chamber 60” (Carr ¶ [0075]). Carr further states that the sealing sleeve prevents air flow around the needle so that the syringe may effectively draw in liquid payload (Carr ¶ [0075]). Carr therefore teaches the suction-creating seal function. For an artisan skilled in the art, the intersection placement is an obvious design location in Carr’s tapered/tiered channel so the seal can transition between the wider proximal tier and narrower distal/filter tier while maintaining suction. In relation to claim 10 , this claim depends from claim 8 and further recites a removable cap positioned over the perforations of the cover member, with a closed distal end sized to receive the closed distal end of the cover member, a proximal end, and a sidewall forming friction engagement with the cover member. Claim 10 is rejected over Carr in view of Adriaantje, as discussed above with respect to claims 1 and 8. Carr discloses the removable outer cap structure. The outer cap has a “closed distal end,” an open proximal portion, and an inner chamber for receiving the filtering needle cap (Carr ¶ [0051]). Carr also states that the filtering needle cap may be secured concentrically within the proximal portion of the outer cap (Carr ¶ [0052]). In the modified combination, where Adriaantje supplies perforations at the distal end of the cover, Carr’s outer cap would naturally be positioned over those perforations during shipping and removed before aspiration. Therefore, in view of the conventionality of the enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the device. In relation to claim 16 , this claim depends from claim 1 and further recites a cylindrical seal at the distal end of the cover member, the seal having a central channel with a proximal portion sized to receive the distal needle end and a narrowed distal portion extending to an opening in the closed distal end, and a filter positioned between the cylindrical seal and closed distal end. Claim 16 is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 1. Carr teaches a sleeve/seal and filter placement near the distal end. Carr states that “a sealing sleeve 50 is secured within the inner wall 52 of the filtering needle cap 14 near the distal portion 26,” that the sleeve has “a cylindrical central opening … sized for receiving the needle,” and that the interference fit forms a seal (Carr ¶¶ [0059] [0060]). Carr also teaches that “a filter element 732 is positioned distal to the sleeve 708” and that the needle fits into the sleeve channel to form a seal (Carr ¶ [0089]). Adriaantje supplies the closed distal end and perforated opening structure. Therefore, for an artisan skilled in the art, it would have been obvious to arrange the Carr seal proximal of the Adriaantje perforated closed end and to place the filter between the seal and distal end so the aspirated solution is filtered before entering the needle lumen. In relation to claim 18 , this claim is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 1. Carr teaches that the filtered needle is used with a syringe or other fitting and that the hub engages the distal end of the syringe. Carr states that the filtered needle “is secured to the end of a syringe … by engagement with the hub 78 at the proximal end 34 of the needle and connector portion 16” (Carr ¶ [0069]). Carr further teaches that after filtration “the syringe is loaded with the desired amount of liquid payload” and the exposed distal needle is ready for use (Carr ¶ [0077]). A syringe barrel and stopper for drawing and expelling liquid are conventional and inherent to Carr’s disclosed syringe operation, but the rejection is not based on inherency alone; Carr expressly states syringe loading and operation to draw liquid through the filtered needle (Carr ¶ [0077]). Therefore, in view of the conventionality of the enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the device. In relation to claim 19 , this claim recites a method of using a fluid delivery device with the needle guard assembly of claim 1, including inserting the assembly into a medical fluid container, drawing medical solution through the cover member and into the lumen, drawing it into the reservoir, and removing the assembly after collecting enough solution. Claim 19 is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 1. Carr teaches the method of loading a filtered needle, including engaging the filtered needle with a syringe, removing the outer cap, immersing the filter element in an ampoule or receptacle, drawing the payload through a defined pathway, trapping debris, and loading the syringe (Carr ¶ [0067]). Adriaantje supplies the closed perforated cover configuration for the “cover member” through which solution passes. The combined method therefore teaches the claimed draw-up process. Therefore, in view of the conventionality of the process, its implementation in the invention of this application would have been considered an obvious alternative in the design of the device. In relation to claim 20 , this claim depends from claim 19 and further recites that the medical fluid container is a glass ampoule and that the method includes breaking a narrow neck of the glass ampoule before insertion. Claim 20 is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 19. Carr expressly teaches the glass-ampoule context: “Liquid pharmaceuticals are typically stored in sealed glass ampoules,” and “the ampoule is opened by snapping the glass neck” (Carr ¶ [0003]). Carr further explains that doing so produces glass shards that must be removed before administration (Carr ¶ [0003]). Therefore, in view of the conventionality of the process, its implementation in the invention of this application would have been considered an obvious alternative in the design of the device . 07-21-aia AIA Claim s 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Carr et al. (US 2016/0067410A1; hereinafter “Carr”) in view of Adriaantje et al. (NL2019483B1; hereinafter “Adriaantje”), as discussed above, Williams et al. (GB2369779A; hereinafter “Williams”) and Ferguson et al. (US2007/0282275A1; hereinafter “Ferguson”) . In relation to claim 11 , this claim depends from claim 1 and further recites that the cover member comprises a cap with an open proximal end, closed distal end, cylindrical sidewall, and first and second arms mounted between the needle hub and cap for moving the cap along the needle cannula between an initial covered position and a retracted position exposing the sharpened tip. Claim 11 is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 1, and in further view of Williams et al. (GB2369779A; hereinafter “Williams”) and Ferguson et al. (US 2007/0282275A1; hereinafter “Ferguson”). Carr and Adriaantje provide the filtered needle assembly and closed perforated distal cover, respectively. The combination of Carr in view of Adriaantje do not disclose the claimed hinged arm mechanism. However, Williams teaches a hinged needle guard in which a sheath is slidably mounted on a needle and moved by an arm. Williams states that the concept is “based on a slideable crank, in which the sheath … moves between a distal position where it encapsulates the distal end of the needle … and a proximal position, where the distal end is exposed.” Williams further states that “a side arm … connects the sheath … to the collar … via an Integral live hinge,” and that the arm articulates between an extended condition with the sheath over the tip and a collapsed condition with the sheath retracted along the shaft (Williams, page 1, first two paragraphs in the section titled: “Detailed Description of the Preferred Embodiment”). Ferguson further teaches a safety shield having “a distal segment, a proximal segment and a foot or retention member,” with hinge members securing the distal and proximal segments. (Ferguson ¶ [0063]). Ferguson also discloses movement from a retracted position to an advanced position to shield a needle (Ferguson ¶ [0064]). Therefore, a person of ordinary skill would have combined the filtered needle of Carr/Adriaantje with the arm-actuated movable sheath of Williams and the retention structures of Ferguson to provide a reusable or deployable cap/cover mechanism that can selectively expose and cover the sharpened needle tip while retaining filtration and safety functions. The motivation is needlestick prevention and controlled exposure of the needle tip, a problem expressly recognized by the safety-shield references. In relation to claim 12 , this claim depends from claim 11 and further recites that the cap slides along the needle cannula between the initial and retracted positions. Claim 12 is rejected over Carr in view of Adriaantje, as discussed above with respect to claim 1, and in further view of Williams and Ferguson, as discussed above with respect to claim 11. Williams expressly teaches a “sheath slidably mounted on said needle” and “longitudinally moveable from a distal position, where the needle is enclosed, to a proximal position, where the needle is exposed” (Williams, claim 1). Therefore, in view of the conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the device. In relation to claim 13 , this claim depends from claim 11 and further recites that the first and second arms each comprise a proximal segment hingedly joined to a distal segment, and the distal segments bend radially inwardly relative to the proximal segments as the arms move from the initial to the retracted position. Williams teaches an arm hinged at or about its center, connected to a sheath and collar, and articulating between stable states (Williams; Abstract and claim 1). Ferguson similarly teaches a safety shield with a distal segment and proximal segment, where the proximal end of the distal segment is pivotally connected to the distal end of the proximal segment (Ferguson, Abstract). Ferguson also teaches hinge members, living hinges, pivot members, and movement of the distal segment relative to the proximal segment (Ferguson ¶ [0063]). Therefore, for an artisan skilled in the art, the claimed inward bending would have been an obvious kinematic consequence of using hinged arms to retract a sliding sheath/cap along the needle. In relation to claim 14 , this claim depends from claim 13 and further recites that the arms are biased to the retracted position and that, in the retracted position, a distal segment of an arm is substantially perpendicular to a longitudinal axis of the needle guard. Williams teaches a spring variant in which a V-shaped spring locks the proximal arm to the lever “in one of two stable states, either extended or retracted,” and causes the mechanism to alternate between sheathed and collapsed states (Williams, page 1, second paragraph from bottom of page). Ferguson teaches that, in a retracted position, the longitudinal axes of the proximal and distal segments are “substantially perpendicular to a longitudinal axis of needle 16” (Ferguson ¶ [0071]). The biasing and perpendicular orientation limitations are therefore taught or suggested by the combined safety-shield references. Therefore, in view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the device. In relation to claim 15 , this claim depends from claim 13 and further recites a retention ring positioned about the needle hub, configured to engage an arm portion for retaining the cap over the distal end, with hooks configured to engage the first and/or second arm for maintaining the arms in the initial position. Ferguson teaches a retaining collar for mounting the shield to a medical needle device, including “a retaining collar 140” pressed over the nose to capture the retention member (Ferguson ¶ [0078]). Ferguson also discloses locking tabs and cutouts that releasably secure the safety shield in its retracted position, and tabs that lock the shield in its advanced position (Ferguson ¶ [0066]). Williams teaches snap-fit locks mounted on the arm and lever for holding the guard in its extended position (Williams, Abstract). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to provide the Carr/Adriaantje filtered cap with a retaining ring/collar and hook or snap-fit features to hold the arms in a desired covered initial position, because the safety-shield references teach such locks to prevent unintended needle exposure. Allowable Subject Matter Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims . The following is an examiner’s statement of reasons for allowance: In relation to the patentability of claim 17 , the prior art of record does not disclose or reasonably suggest, an elastomeric ring positioned about an outer surface of the tubular body of the needle cannula , wherein the cover member comprises at least one slot configured to receive the elastomeric ring for retaining the ring within the cover member as the cover member is removed from the needle cannula, thereby removing the ring from the needle cannula, and wherein the cover member is configured such that the ring is received within the at least one slot as the cover member is removed from the needle cannula, and the ring slides past the at least one slot without being received in the at least one slot as the needle cannula is inserted into the cover member. 13-03 Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” 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: 18/613,659 Page 2 Art Unit: 3783 Application/Control Number: 18/613,659 Page 3 Art Unit: 3783 Application/Control Number: 18/613,659 Page 4 Art Unit: 3783 Application/Control Number: 18/613,659 Page 5 Art Unit: 3783 Application/Control Number: 18/613,659 Page 6 Art Unit: 3783 Application/Control Number: 18/613,659 Page 7 Art Unit: 3783 Application/Control Number: 18/613,659 Page 8 Art Unit: 3783 Application/Control Number: 18/613,659 Page 9 Art Unit: 3783 Application/Control Number: 18/613,659 Page 10 Art Unit: 3783 Application/Control Number: 18/613,659 Page 11 Art Unit: 3783 Application/Control Number: 18/613,659 Page 13 Art Unit: 3783 Application/Control Number: 18/613,659 Page 14 Art Unit: 3783 Application/Control Number: 18/613,659 Page 15 Art Unit: 3783 Application/Control Number: 18/613,659 Page 16 Art Unit: 3783
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