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 .
This office action is in response to applicant’s communication of 3/27/2024. Currently claims 68-102 are pending and rejected below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/4/2026 and 3/27/2024 is being considered by the examiner.
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)(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) 68-100, and 102 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Halseth (WO 01/78595 A1).
Halseth discloses a catheter assembly (see figures 15-17 for example) comprising: a catheter tube (430) attached to a catheter hub (420) and a needle (465) attached to a needle hub, wherein the needle is located in a lumen of the catheter tube and a needle tip of the needle projects out a distal opening of the catheter tube; an adaptor (450) having a body comprising a base, a tip, and a bore extending through the body, the base having a base bore section and the tip having a tip bore section (470/472), the tip located in a proximal opening of the needle hub; and a guidewire dispenser having a frame with a plurality of branches, a connection tip at a first branch (480) of the plurality of branches located inside the base bore section of the adaptor; and wherein a guidewire (468) extends through a second branch (487) of the plurality of branches and in through the connection tip at the first branch.
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Concerning claim 69 and a housing comprising a first frame (325) attached to a second frame (327) and having an interior space, said housing having a distal opening and a proximal opening and the catheter hub is located at least in part in the interior space of the housing (figures 12-13).
Concerning claim 70 and comprising a duct having a first end (near 487) attached to a socket at the second branch and wherein the guidewire extends at least partially into the duct (figure 17).
Concerning claim 71 the duct has a second end attached to a socket of a third branch (485) of the plurality of branches (as in figure 17).
Concerning claim 72 and a valve (472) located in the bore of the adaptor.
Concerning claim 73 and a needle guard located in an interior cavity of the catheter hub (see 430).
Concerning claim 74 and the guidewire has at least two guidewire sections with at least two different diameters (note guidewire has a different diameter at the bend section or at natural curvature vs straight section).
Concerning claim 75 and the tip of the adaptor comprises a plurality of spaced apart gas channels (note multiple channels of 450).
Concerning claim 76 and a plurality of spaced apart elongated ribs located on an exterior of the tip, and wherein a ravine comprising a width and a length is defined between two adjacent elongated ribs (see portions ribs and ravines near 454 and 452 as in figure 15-16).
Concerning claim 77 and the guidewire comprises a shoulder or a gradual taper located at a point between the distal guidewire section and the proximal guidewire section (note guidewire has a different taper at the bend section or at natural curvature vs straight section).
Concerning claim 78 and the distal guidewire section passes through the needle at the crimp and extends out an opening at the needle tip (see exit near 468).
Concerning claim 79 and the tip of the adaptor comprises a cannula channel having an inside measurement and a guidewire passage having an inside measurement, and wherein the inside measurement of the cannula channel is larger than the inside measurement of the guidewire passage (see figure 15-16 and 450).
Concerning claim 80 and the cannula channel is located distal of the guidewire passage (see cannula channel distal to guidewire passage near 472).
Concerning claim 81 and the base of the adaptor is formed with a plurality of slats (see slats near 454 or 451 as in figures 15-16).
Concerning claim 82 and the body at the tip of the adaptor has a cannula channel having an interior surface defining a non-circular cross-sectional opening (see portion cross section near 443/440).
Concerning claim 83 and the plurality of branches comprises at least three branches, which include a first branch, a second branch, and a third branch (see 480/487/485 branches).
Concerning claim 84 and a tubing having a first end, a second end, and a lumen and wherein the guidewire is disposed at least in part in the lumen of the tubing (see tubing 430).
Concerning claim 85 and the plurality of gas channels comprises four to twelve gas channels (see channels 474/470/456 and 454).
Concerning claim 86 and A catheter assembly comprising: a catheter tube (430) attached to a catheter hub (420) and a needle (465) having a needle tip attached to a needle hub, wherein the needle projects through the catheter tube and the needle tip disposed distally of a distal opening of the catheter tube; an adaptor (450) having a body with an exterior surface and an interior surface defining a bore, the body further having a base having a base bore having a valve chamber (area near 472) and a valve (472) comprising at least one slit and two flaps located in the valve chamber and a tip having a guidewire passage (interior), said tip located in a proximal opening of the needle hub; and a guidewire dispenser having a tip (480) disposed in the bore of the adaptor and a guidewire (468) having a first end disposed in the bore of the adaptor.
Concering claim 87 and a plurality of spaced apart gas channels disposed on the exterior surface of the body of the adaptor (see channels 474/470/456 and 454).
Concerning claim 88 and a plurality elongated ribs disposed on the exterior surface of the body of the adaptor (see portions ribs near 454 and 452 as in figure 15-16).
Concerning claim 89 and an adaptor (450) for use to guide a guidewire (468) through a needle lumen comprising:a body comprising a base , a tip , and a bore extending through the body ; the base having a base bore section and the tip having a tip bore section; at least one of a cannula channel at the tip having a plurality of generally straight sides with two adjacent plurality of straight sides connected to one another by an arcuate connecting portion and sized to receive a needle shaft and a valve comprising a wall having at least one slit positioned in the base bore of the base ; wherein the base comprises a proximal opening sized and shaped for receiving a tip of a guidewire dispenser and a first engagement structure for engaging a second engagement structure on the tip of the guidewire dispenser (see figures 17).
Concerning claim 90 and the base has a non-circular cross-section having a plurality of slats or sidewalls (see area near 443 and slats).
Concerning claim 91 and the first engagement structure extends from one of the plurality of slats or sidewalls (see structure near 440).
Concerning claim 92 and the cannula channel (near 450) has a first inside cross- sectional dimension and a guidewire passage (near 470) having a second inside cross-sectional dimension located proximally of the cannula channel; and wherein the first inside cross-sectional dimension is greater than the second inside cross-sectional dimension (see figure 15-16).
Concerning claim 93 and the cannula channel has a plurality of generally straight sides and wherein two adjacent generally straight sides are connected by an arcuate connecting portion (see straight sides 456/470 and connection by arcuate connection near 452).
Concerning claim 94 and the valve (472) has a skirt extending from the wall (see sides of valve 472).
Concerning claim 95 and the wall of the valve (474) has a first portion with a first thickness and a second portion with a second thickness and wherein the first thickness is greater than the second thickness, measured orthogonal to a medial plane passing through the wall (note table top portion of the wall has an outer thickness greater than the inner thickness).
Concerning claim 96 and the valve is located between two internal shoulders of the base (see shoulders near 472 and 474).
Concerning claim 97 and the tip having the tip bore section with a frustoconical shape (see figure 15-16 and note frustoconical shape of tip).
Concerning claim 98 and a guidewire dispenser (figure 17) comprising:a frame with a plurality of branches, including a first branch (480) and a second branch (487); a connection tip (482) at the first branch, said connection tip comprising a lumen; a guide bracket (near 487 window) at the second branch and a lumen formed through guide bracket, said guide bracket comprising a socket (end portion); a tubing (485) having a first free end and a second free end, said first free end located in the socket and said second free end held by a retaining clip or by socket located on a third branch (485); a guidewire (468) having a length with a first free end and a second free end, said guidewire located in said tubing and extending through the socket at the second branch and into the lumen of the connection tip; and wherein the guidewire is exposed between the first branch and the second branch (see window near 468 in figure 17).
Concerning claim 99 and the third branch has an enclosed wall at an end of the socket (see branch 485 and enclosed wall).
Concerning claim 100 and the second branch is located higher, elevation-wise, than the first branch (note branch 487 is higher than 480).
Concerning claim 102 and the frame has a Y-shape configuration (see figure 17 and “y” shape of 487/485/480).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halseth (WO 01/78595 A1) in view of Lynch et al. (US 4/860,757).
Halseth discloses the claimed invention except for the frame in a closed loop. Lynch teaches that it is known to use frame in a closed loop as set forth in figure 1 and frame 11) to provide a protected means to advance a guidewire in to tubing. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Halseth with frame in a closed loop as taught by Lynch, since such a modification would provide the system with frame in a closed loop for providing a protected means to advance a guidewire in to tubing
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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