DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Specification The abstract of the disclosure is objected to because there appears to be a typo regarding “The needle hub has aa distal path” as opposed to “The needle hub has a distal path…”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). The disclosure is objected to because of the following informalities: In paragraph [0130], “the tubing 148” should be corrected to “the tubing 158 ” In paragraphs [0143] and [0147], “the catheter unit 104” should be corrected to “the catheter unit 102 ” In paragraph [0154], “the ultrasound probe 116” should be corrected to “the ultrasound probe 226 ” In paragraph [0158], “the catheter hub 110” should be corrected to “the needle hub 110” In paragraph [0159], “the working platform 134” should be corrected to “the working platform 136 ” Appropriate correction is required. Claim Objections Claim 36 is objected to because there is a typo regarding “passing a guidewire through proximal path,…” as opposed to “passing a guidewire through the proximal path,…” in line 14. 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 appl icant regards as his invention. Claims 34-35 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. Regarding claim 34, the limitation “a guidewire is partly located inside the tubing and partly located inside the needle” in lines 2-3 renders the claim indefinite. It is unclear if the catheter assembly includes two guidewires: “ a guidewire extends through both the distal path, the proximal path, and at least part of the needle lumen ” as required by claim 21 and also a second “a guidewire” partly located inside the tubing and needle as required by claim 34 , or if “a guidewire” introduced in claim 34 is the same guidewire introduced in claim 21. For examination purposes, “a guidewire” introduced in claim 34 has been interpreted to be the same guidewire introduced in claim 21. It is suggested to amend claim 34 to: “ The catheter assembly according to claim 21, wherein a tubing is attached to the needle hub and wherein a the guidewire is partly located inside the tubing and partly located inside the needle. ”, or similar. Claim 35 is rejected for being dependent on claim 34. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claims 21 , 23-31, and 34- 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ornelas Vargas et al. (US 20180126126). Regarding claim 21, Ornelas Vargas discloses a catheter assembly (insertion device 10; Figures 1-4) comprising: a catheter unit (sheath movement element 70 and sheath 71) comprising a catheter hub (proximal end of sheath 71; Figure 3) having a hub body with a proximal opening (at connection sheath hub 74; Figure 4) and having a catheter tube (body of sheath 71) extending from a distal end of the catheter hub, the catheter tube having a catheter tube opening (Figures 3-4) ; an integrated needle unit (main housing 20 with attached needle 40) comprising a needle hub (main housing 20) with a body (Figures 1-4) and having a needle (needle 40) with a needle lumen extending out a distal end of the needle hub (Figure 4) , wherein the needle hub comprises: a distal path (lumen 36) having a distal path opening (opening 27) and having the needle attached to an end of the distal path (Figure 4) ; a proximal path ( from protrusion 65 through guidewire housing connector 68) having a proximal path opening (opening from guidewire feed region 64 into guidewire housing connector 68; Figure 4) and a rear-most opening (opening from guidewire housing connector 68 into guidewire housing 62; Figure 4) ; a working surface (surface of guidewire feed region 64 having protrusion 65) on a working platform (guidewire feed region 64) located between the distal path opening and the proximal path opening (Figure 4; “ , guidewire feed region 64 includes protrusion 65 between guidewire housing connector 68 and opening 27 to lumen 36, over which guidewire 60 passes. ” [0055]) ; and wherein the working surface is exposed from a side of the body (Figures 1-4) , and wherein a guidewire (guidewire 60) extends through both the distal path, the proximal path, and at least part of the needle lumen (“ Main housing 20 is configured to allow the movement of guidewire 60 from the distal end of guidewire housing 62 at or about connector 68 along guidewire feed region 64 into lumen 36 of main housing 20. Lumen 36 connects with lumen 35 in the main housing 20 at a point proximal to the connection of needle hub 37 to needle hub attachment 26. Lumen 36 is configured to receive guidewire 60 at opening 27. ” [0054]; “ the thumb of the user can be used to advance guidewire 50 through needle 40 toward distal end 40B of needle 40 and into the targeted body space of the patient. ” [0055]); and wherein the assembly is configured such that, after advancement of the guidewire, the catheter tube is configured to advance over the guidewire causing the catheter hub to separate from the needle hub such that the needle hub, the needle, and the guidewire are completely separated from the catheter hub, when the needle hub and the catheter hub are moved away from one another (“ Sheath 71 … may be removably attached, depending on the application and the specific use of the embodiment. Where sheath 71 is removably attached, sheath attachment would be configured so that sheath can be left in the tissue of the patient to provide a port through which the targeted tissue can be accessed . In this embodiment, sheath movement element 70 includes pusher 72, spanning element 73, sheath hub 74, tab 75, and groove connector 76. Pusher 72 is configured to permit a user, while gripping main housing 20 with a single hand, to move sheath movement element 70 in proximal and distal directions using the thumb of the single hand. Movement of sheath movement element 70 in a distal direction would result in sheath 71 moving coaxially along needle 40 toward the needle distal end 40B. ” [0056]) . Regarding claim 23 , Ornelas Vargas discloses t he catheter assembly of claim 21, wherein a tubing (guidewire housing 62; Figure 1) having a first end is coupled directly to the needle hub (“ guidewire housing 62 is removably attached to main housing 20 at connector 68 ” [0054]) . Regarding claim 24 , Ornelas Vargas discloses th e catheter assembly of claim 23, wherein the first end projects into the rear-most opening of the needle hub (Figure 4; “ guidewire housing 62 is removably attached to main housing 20 at connector 68 ” [0054]) . Regarding claim 25 , Ornelas Vargas discloses t he catheter assembly of claim 23, wherein the guidewire is partly located inside the tubing (“ guidewire 60 is disposed within guidewire housing 62 ” [0054]; Figure 4) . Regarding claim 26 , Ornelas Vargas discloses t he catheter assembly according to claim 23, wherein the tubing has a second end (proximal end of guidewire housing 62 having cap 63) and wherein the second end is unsupported or wherein the second end is s upported by a socket located on the needle hub (Figure 2 showing unsupported proximal end of guidewire housing 62) . Regarding claim 27 , Ornelas Vargas discloses t he catheter assembly according to claim 21, wherein the guidewire (guidewire 60) has a proximal end (at cap 63) and wherein the proximal end is sized and shaped to abut the rear-most opening of the needle hub to stop distal movement of the guidewire (“ Guidewire housing 62 may additionally include a cap 63. If present, cap 63 could serve a variety of purposes, including … to prevent guidewire 60 from being pushed out the proximal end of guidewire housing 62. ” [0054]) or wherein the guidewire has an enlarged section and wherein the enlarged section is sized and shaped to abut a crimp on the needle from inside the needle to stop distal movement of the guidewire. Regarding claim 28 , Ornelas Vargas discloses t he catheter assembly according to claim 21, wherein the needle hub has a first proximal path section (between protrusion 65 and connector 68) and a guide stub (connector 68) extending from a proximal end surface of the needle hub and a second proximal path section (through connector 68) aligned with the first proximal path section (Figure 4) . Regarding claim 29 , Ornelas Vargas discloses t he catheter assembly according to claim 21, wherein the needle hub has a receiving cavity at the distal pat h (Figure 4; “ Lumen 36 is further configured to be fitted with a valve 28 between opening 27 and the point where lumen 36 joins with lumen 35 ” [0054]). Regarding claim 30 , Ornelas Vargas discloses th e catheter assembly according to claim 21, further comprising a flow restrictor (valve 28) located in the receiving cavity, said flow restrictor comprising one of a septum, a valve , or a hydrophobic filter (“ Lumen 36 is further configured to be fitted with a valve 28 between opening 27 and the point where lumen 36 joins with lumen 35. Valve 28 is configured to allow the passage of guidewire 50 but to prevent the substantial flow of air that would substantially defeat a vacuum created by the proximal movement of plunger 52 in vacuum chamber 50. ” [0054]) . Regarding claim 31 , Ornelas Vargas discloses t he catheter assembly according to claim 21, wherein the needle hub has a channel (through main lumen 35, lumen 36, and extending through connector 68) and wherein the working platform is part of the channel (Figure 4) and the channel having s idewalls extending from the working surface (walls forming guidewire feed region 64; Figures 1-4) . Regarding claim 34 , Ornelas Vargas discloses t he catheter assembly according to claim 21, wherein a tubing (guidewire housing 62; Figure 1) is attached to the needle hub (“ guidewire housing 62 is removably attached to main housing 20 at connector 68 ” [0054]) and wherein a guidewire (guidewire 60) is partly located inside the tubing and partly located inside the needle (“ guidewire 60 is disposed within guidewire housing 62 ” [0054]; “ the thumb of the user can be used to advance guidewire 50 through needle 40 toward distal end 40B of needle 40 and into the targeted body space of the patient. ” [0055]) . Regarding claim 35 , Ornelas Vargas discloses t he catheter assembly of claim 34, wherein the guidewire (guidewire 60) passes through both the distal path and the proximal path (Figure 4; “ Main housing 20 is configured to allow the movement of guidewire 60 from the distal end of guidewire housing 62 at or about connector 68 along guidewire feed region 64 into lumen 36 of main housing 20. Lumen 36 connects with lumen 35 in the main housing 20 at a point proximal to the connection of needle hub 37 to needle hub attachment 26. Lumen 36 is configured to receive guidewire 60 at opening 27. ” [0054]) . Regarding claim 36, Ornelas Vargas discloses a method of manufacturing a catheter assembly (insertion device 10; Figures 1-4) comprising: forming a catheter unit (sheath 71 and sheath hub 74) comprising a catheter hub (sheath hub 74) having a hub body with a proximal opening (Figure 4) and having a catheter tube (sheath 71) extending from a distal end of the catheter hub , the catheter tube having a catheter tube opening (Figure 4) ; forming an integrated needle unit (main housing 20 with attached needle 40 ) comprising a needle hub ( main housing 20 ) with a body (Figure s 1-4 ) and having a needle (needle 40) with a needle lumen extending out a distal end of the needle hub (Figure 4) , wherein the needle hub comprises: a distal path (lumen 36) having a distal path opening (opening 27) and having the needle attached to an end of the distal path (Figure 4) ; a proximal path (guidewire housing connector 68) having a proximal path opening ( opening from guidewire feed region 64 into guidewire housing connector 68; Figure 4 ) and a rear-most opening (opening from guidewire housing connector 68 into guidewire housing 62; Figure 4) ; a working surface (surface of guidewire feed region 64 having protrusion 65) on a working platform (guidewire feed region 64) located between the distal path opening and the proximal path opening (Figure 4; “ , guidewire feed region 64 includes protrusion 65 between guidewire housing connector 68 and opening 27 to lumen 36, over which guidewire 60 passes. ” [0055]) ; and wherein the working surface is exposed from a side of the body (Figures 1-4) , and passing a guidewire (guidewire 60) through proximal path, through the distal path, and at least partly into the needle lumen (“ Main housing 20 is configured to allow the movement of guidewire 60 from the distal end of guidewire housing 62 at or about connector 68 along guidewire feed region 64 into lumen 36 of main housing 20. Lumen 36 connects with lumen 35 in the main housing 20 at a point proximal to the connection of needle hub 37 to needle hub attachment 26. Lumen 36 is configured to receive guidewire 60 at opening 27. ” [0054]; “ the thumb of the user can be used to advance guidewire 50 through needle 40 toward distal end 40B of needle 40 and into the targeted body space of the patient. ” [0055]) . Regarding claim 37 , Ornelas Vargas discloses t he method of claim 36, further comprising exposing the guidewire at the working surface between the proximal path and through the distal path for pushing by a user (Figure 4; “ guidewire feed region 64 includes protrusion 65 between guidewire housing connector 68 and opening 27 to lumen 36, over which guidewire 60 passes. Guidewire feed region 64 is generally configured to be accessible by the thumb of the user while gripping main housing 20 with one hand … the thumb of the user can be used to advance guidewire 50 through needle 40 toward distal end 40B of needle 40 and into the targeted body space of the patient. ” [0055]) . Regarding claim 38 , Ornelas Vargas discloses t he method of claim 36, further comprising placing a flow restrictor (valve 28) into a receiving cavity formed at a distal end of the needle hub (“ Lumen 36 is further configured to be fitted with a valve 28 between opening 27 and the point where lumen 36 joins with lumen 35. Valve 28 is configured to allow the passage of guidewire 50 but to prevent the substantial flow of air that would substantially defeat a vacuum created by the proximal movement of plunger 52 in vacuum chamber 50. ” [0054]) . Regarding claim 39, Ornelas Vargas discloses a method of using a catheter assembly (insertion device 10; Figures 1-4) comprising: gripping the catheter assembly with one hand to grip the catheter assembly with a h olding hand (“ Handles 21A and 21B are configured to facilitate a user gripping and operating the insertion device using one hand ” [0051]; “ Guidewire feed region 64 is generally configured to be accessible by the thumb of the user while gripping main housing 20 with one hand ” [0055]) , the catheter assembly comprising: a catheter unit (sheath 71 and sheath hub 74) comprising a catheter hub (sheath hub 74) having a hub body with a proximal opening (Figure 4) and having a catheter tube (sheath 71) extending from a distal end of the catheter hub , the catheter tube having a catheter tube opening (Figure 4) ; an integrated needle unit (main housing 20 with attached needle 40 ) comprising a needle hub ( main housing 20 ) with a body (Figure 3) and having a needle (needle 40) with a needle lumen extending out a distal end of the needle hub (Figure s 1-4 ) , wherein the needle hub comprises: a distal path (lumen 36) having a distal path opening (opening 27) and having the needle attached to an end of the distal path (Figure 4) ; a proximal path (guidewire housing connector 68) having a proximal path opening (opening from guidewire feed region 64 into guidewire housing connector 68; Figure 4) and a rear-most opening (opening from guidewire housing connector 68 into guidewire housing 62; Figure 4) ; a working surface (surface of guidewire feed region 64 having protrusion 65) on a working platform (guidewire feed region 64) located between the distal path opening and the proximal path opening (Figure 4; “ , guidewire feed region 64 includes protrusion 65 between guidewire housing connector 68 and opening 27 to lumen 36, over which guidewire 60 passes. ” [0055]) ; and wherein the working surface is exposed from a side of the body (Figures 1-4) , and orienting a finger of the holding hand over the working platform (“ Guidewire feed region 64 is generally configured to be accessible by the thumb of the user while gripping main housing 20 with one hand; however, the configuration may be altered in some embodiments of the present inventions such that the guidewire feed region 64 is accessible by a finger of the one hand of the user gripping main housing 20. In this embodiment, the thumb of the user can be used to advance guidewire 50 through needle 40 toward distal end 40B of needle 40 and into the targeted body space of the patient. ” [0055]) . Regarding claim 40 , Ornelas Vargas discloses t he method of claim 39, wherein a guidewire (guidewire 60) passes between the distal path and the proximal path (“ Main housing 20 is configured to allow the movement of guidewire 60 from the distal end of guidewire housing 62 at or about connector 68 along guidewire feed region 64 into lumen 36 of main housing 20. Lumen 36 connects with lumen 35 in the main housing 20 at a point proximal to the connection of needle hub 37 to needle hub attachment 26. Lumen 36 is configured to receive guidewire 60 at opening 27. ” [0054]) , and further comprising pushing down on the guidewire with the finger to press the guidewire between the finger and the working surface (“ the thumb of the user can be used to advance guidewire 50 through needle 40 toward distal end 40B of needle 40 and into the targeted body space of the patient … Protrusion 65 can serve to provide tactile feedback to the clinician while advancing (or retracting) guidewire 60, as well as to provide a raised surface to press against while advancing guidewire 60 to assist in the gripping of guidewire 60 to increase the efficiency of movement of guidewire 60. ” [0055]) . 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 22 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Ornelas Vargas et al. (US 20180126126) in view of Teoh (US 20160331937) . Regarding claim 22, Ornelas Vargas discloses t he catheter assembly of claim 21 . Ornelas Vargas fails to explicitly disclose the proximal opening of the hub body of the catheter hub comprises a female Luer receiving a distal end of the needle hub. Teoh teaches a catheter assembly (needle assembly 10) comprising a catheter unit (catheter tube 16 and catheter hub 18) comprising a catheter hub having a hub body (catheter hub 18) and a having a catheter tube (catheter tube 16) and an integrated needle unit (needle 12 and needle hub 14) comprising a needle hub (needle hub 14); wherein a proximal opening of the hub body of the catheter hub comprises a female Luer (proximal opening 48 having exterior threads 38; “ The proximal hub opening 48 is sized and shaped to receive a male medical implement, such as a Luer tip, a syringe tip, or a Luer adaptor. ” [0041]) receiving a distal end of the needle hub (Figure 1A) . Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter hub of Ornelas Vargas to include t he proximal opening of the hub body of the catheter hub comprises a female Luer receiving a distal end of the needle hub based on the teachings of Teoh to both releasably secure the needle unit to the catheter unit and to allow the catheter unit to be coupled to a medical implement after the catheter unit has been separated from the integrated needle unit (Teoh [0041]; Figures 1A-1B). Regarding claim 32 , Ornelas Vargas discloses th e catheter assembly according to claim 21 . Ornelas Vargas fails to explicitly disclose a needle guard located in an interior of the catheter hub, said needle guard comprising two arms biased outwardly by the needle. Teoh teaches a catheter assembly (needle assembly 10) comprising a catheter unit (catheter tube 16 and catheter hub 18) comprising a catheter hub (catheter hub 18) and an integrated needle unit (needle 12 and needle hub 14) comprising a needle (needle 12); further comprising a needle guard (needle guard 20) located in an interior of the catheter hub (Figure 1A) , said needle guard comprising two arms (two arms 26) biased outwardly by the needle (“ The exemplary needle guard 20 can comprise a proximal wall 24 having an opening for slidably receiving the needle 12, two arms 26 extending distally of the proximal wall 24, and a distal wall 28 located on each arm for blocking the needle tip 2 2” [0039]; Figure 1A). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter hub of Ornelas Vargas to include a needle guard located in an interior of the catheter hub, said needle guard comprising two arms biased outwardly by the needle based on the teachings of Teoh to cover the distal tip of the needle after use of the catheter assembly (Teoh [0039]). Regarding claim 33 , modified Ornelas Vargas teaches t he catheter assembly of claim 32 . Modified Ornelas Vargas fails to explicitly disclose a valve and a valve opener located in the interior of the catheter hub. Teoh teaches a catheter assembly (needle assembly 10) comprising a catheter unit (catheter tube 16 and catheter hub 18) comprising a catheter hub (catheter hub 18) and an integrated needle unit (needle 12 and needle hub 14); further comprising a valve (valve 34) and a valve opener (valve opening 36) located in the interior of the catheter hub (Figure 1A). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter hub of Ornelas Vargas to include a valve and a valve opener located in the interior of the catheter hub based on the teachings of Teoh prevent fluid flow when nothing is extended through the catheter unit and allow fluid flow when a medical implement is coupled to the catheter unit after the catheter unit is detached from the integrated needle hub (Teoh [0040-0041]). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Weinstein (USPN 5158544) discloses a catheter assembly (Figure 1) comprising a catheter unit (20) comprising a catheter hub (21) and a catheter tube (22); an integrated needle unit (10) comprising a needle hub (12), a needle (10), and a guidewire (15); wherein the catheter unit is configured to completely separate from the integrated needle unit ( [Col 3, lines 25-30] ). Jesch (USPN 5512052) discloses a catheter assembly ( Figures 1-6 ) comprising a catheter unit (13) comprising a catheter hub ( 41 ) and a catheter tube ( 40 ); an integrated needle unit (10, 12) comprising a needle hub ( 16 ), a needle ( 11 ), and a guidewire ( 23 ); wherein the catheter unit is configured to completely separate from the integrated needle unit ( [Col 6, lines 29-59] ). Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LEAH J SWANSON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0394 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9 AM- 5 PM ET . 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 Kevin Sirmons can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-4965 . 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. /LEAH J SWANSON/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783