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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/08/2025, 08/08/2025, 11/20/2025, 02/19/2026, and 06/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Species B (FIG. 8) to include claims 4, 5, 11, and 20 in the reply filed on 06/09/2026 is acknowledged.
Claim Rejections - 35 USC § 103
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 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.
Claims 4, 5, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Osman (Pat. No.: US 11,559,646) in view of Salamini et al. (Pub. No.: US 2020/0281503).
Consider claim 4, Osman discloses an optical-fiber stylet holder (col. 8, lines 22-61, Figs. 1, 2, connection hub 128), comprising:
a housing including a housing through hole dimensioned to accept an optical-fiber stylet therethrough (col. 8, lines 22-61, Figs. 1, 2, a stylet port 134 dimensionally adapted for receiving a fiber optic stylet 116);
an insert partially disposed in the housing and partially extending as a button from a side of the housing perpendicular to the housing through hole, the insert including an insert through hole coincident with the housing through hole (col. 8, line 62 thru col. 9, line 16, Figs. 1, 2, release lock 138 that removably extends within the stylet port 134 to selectively engage the fiber optic stylet 116); and
a spring configured to push or pull the insert toward the side of the housing from which the insert extends (col. 8, line 62 thru col. 9, line 16, Figs. 1, 2, release lock 138 may comprise a spring-toggle member), the optical-fiber stylet acting as a stop to the insert being pushed or pulled toward the side of the housing when the optical-fiber stylet is inserted through both the housing through hole and the insert through hole, the optical-fiber stylet holder thereby providing a locking mechanism configured to lock the optical-fiber stylet in the optical-fiber stylet holder and prevent distal movement of the optical-fiber stylet while the optical-fiber stylet is disposed in a hollow needle (col. 8, line 62 thru col. 9, line 16, Figs. 1, 2, the release lock 138 is used to prevent the fiber optic stylet 116 from moving when the distal end 166 of the fiber optic stylet 116 is coplanar with the beveled tip of the hollow needle 132).
Osman does not specifically disclose the optical-fiber stylet is disposed in a catheter.
Salamini discloses the optical-fiber stylet is disposed in a catheter (paragraphs [0119], [0136], a stylet that runs through the catheter).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the hollow needle as disclosed by Osman with the catheter as taught by Salamini in order that the vascular catheter may be advanced so that the distal tip of the catheter is at a known position relative to the distal tip of the stylet/guidewire (Salamini, paragraph [0136]).
Consider claim 5, Osman does not specifically disclose wherein the optical-fiber stylet holder is configured to couple to a Luer connector of the catheter.
Salamini discloses wherein the optical-fiber stylet holder is configured to couple to a Luer connector of the catheter (paragraph [0146], Fig. 10, locking device 1022 may be used to lock the stylet to the proximal end of the catheter using luer lock 1020 at the proximal end of catheter 1018).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the optical-fiber stylet holder as disclosed by Osman with the optical-fiber stylet holder as taught by Salamini so that the stylet/guidewire won't move with respect to the vascular catheter (Salamini, paragraph [0146]).
Consider claim 11, Osman discloses a method of an optical-fiber stylet holder (col. 7, lines 41-54, a method including a fiber optic port for receiving a fiber optic stylet), comprising:
inserting an optical-fiber stylet into the optical-fiber stylet holder (col. 8, lines 22-61, Figs. 1, 2, a stylet port 134 dimensionally adapted for receiving a fiber optic stylet 116);
advancing the optical-fiber stylet through a hollow needle (col. 8, lines 22-61, Figs. 1, 2, the fiber optic stylet 116 to passes through the inner space of the connection hub 128, and slide within the hollow needle 132);
advancing a distal tip of the optical-fiber stylet through a vasculature to a target anatomical location in a patient (col. 8, line 62 thru col. 9, line 16, Figs. 1, 2, the fiber optic stylet 116 end enters a patient's anatomical regions or area such as through the skin or when entering the cricothyroid membrane, or to advance the distal end 166 of the fiber optic stylet 116 into a patient's trachea lumen); and
holding the distal tip of the optical-fiber stylet in the target anatomical location without at least distal advancement of the distal tip by locking the optical-fiber stylet in the optical-fiber stylet holder (col. 8, line 62 thru col. 9, line 16, Figs. 1, 2, the release lock 138 is used to prevent the fiber optic stylet 116 from moving when the distal end 166 of the fiber optic stylet 116 is coplanar with the beveled tip of the hollow needle 132).
Osman does not specifically disclose advancing the optical-fiber stylet through a catheter.
Salamini discloses advancing the optical-fiber stylet through a catheter (paragraphs [0119], [0136], a stylet that runs through the catheter).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the hollow needle as disclosed by Osman with the catheter as taught by Salamini in order that the vascular catheter may be advanced so that the distal tip of the catheter is at a known position relative to the distal tip of the stylet/guidewire (Salamini, paragraph [0136]).
Consider claim 20, the combination of Osman and Salamini discloses comprising:
pressing a button of an insert extending from a side of a housing of the optical-fiber stylet holder to pull or push a spring to allow the optical-fiber stylet to freely move through both housing and insert through holes for adjusting a position of the optical-fiber stylet holder on the optical-fiber stylet (col. 8, line 62 thru col. 9, line 16, Figs. 1, 2, release lock 138 may comprise a spring-toggle member and a push in and out contactor used so that the fiber optic stylet 116 and needle ends can simultaneously enter a patient's anatomical regions or area such as through the skin or when entering the cricothyroid membrane, or to advance the distal end 166 of the fiber optic stylet 116 into a patient's trachea lumen); and
releasing the button to push or pull the insert by way of the spring toward the side of the housing from which the insert extends, thereby locking the optical-fiber stylet in the optical-fiber stylet holder as a stop in the housing and insert through holes and holding the distal tip of the optical-fiber stylet in the target anatomical location (col. 8, line 62 thru col. 9, line 16, Figs. 1, 2, release lock 138 may comprise a spring-toggle member and a push in and out contactor used to prevent the fiber optic stylet 116 from moving when the distal end 166 of the fiber optic stylet 116 is coplanar with the beveled tip of the hollow needle 132).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD JOHNSON whose telephone number is (571)270-7685. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carey Michael can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Gerald Johnson/
Primary Examiner, Art Unit 3797
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