DETAILED ACTION
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) 1-3, 6, 9-13, 15, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Franklin et al. (US 2020/0197682).
As to claim 1, Franklin teaches an insertion system (40) comprising: a main body (41); a side port (41a) mounted at an angle relative to the main body (Fig. 4B) and sized to receive a guide wire ([0072] - guidewire channel 41a); one or more wire guides mounted to the main body and aligned with the side port ([0072] - guidewire 43 is mounted to the hub via guidewire clip and extends from the guidewire channel 41a); and a handle mounted to the main body (Fig. 4; [0073] - lower barrel portion of hub 41 to which a hinged trigger 46a is attached, implying that it’s used as a handle).
As to claim 2, Franklin teaches the main body includes a central lumen (41c), and wherein the side port connects to the central lumen (Fig. 4B - connection between 41a and 41c).
As to claims 3 and 19, Franklin teaches a needle mount (41d) mounted to a proximal end of the main body (41), wherein the needle mount secures a needle to the main body (Fig. 4B - proximal end of needle 42b being secured at the needle mount 41d).
As to claim 6, Franklin teaches the side port is mounted to a top side of the main body and the handle is mounted to a bottom side of the main body (Fig. 4B).
As to claim 9, Franklin teaches the one or more wire guides include openings configured to receive the guide wire and guide the guide wire to the side port (Fig. 4B - 41x; [0072])
As to claims 10 and 18, Franklin teaches an occlusive diaphragm (45) mounted within the side port ([0072], [0113]).
As to claim 11, Franklin teaches a device mount (87b) at a distal end of the main body (Fig. 8B), wherein the device mount is configured to attach to a pressure transducer (100) to determine a pressure within the main body of the insertion system ([0088]).
As to claim 12, Franklin teaches a guide wire (43) and a needle (42), wherein the guide wire is inserted through the side port and into a lumen of the main body (Fig. 4; [0074]), and wherein the needle is mounted to a proximal end of the main body (Fig. 4).
As to claims 13 and 20, Franklin an indicator (160) on the guide wire ([0101]), wherein the indicator is positioned such that the indicator is at a distal end of the side port when a proximal end of the guide wire is positioned at a proximal end of the main body ([0101-0102]).
As to claim 15, Franklin teaches a method of forming an insertion system (40), the method comprising: forming a main body (41) that includes a central lumen (41c); forming a side port (41a) that connects to the main body at an angle (Fig. 4B), wherein the side port is sized to receive a guide wire ([0072]); forming one or more wire guides that connect to a top side of the main body and that are aligned with the side port ([0072]); and forming a handle that connects to a bottom side of the main body ([0073] - lower barrel portion of hub 41)
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2020/0197682) in view of Hartley et al. (US 2011/0230947).
As to claim 4, Franklin does not teach a needle mount comprising a male Luer lock. Hartley teaches a wire guide with an introducer needle in which a male Leur lock connector hub is attached at a distal end of a guide wire catheter for connections to syringes or other medical apparatus ([0048]). It would have been obvious to modify Franklin with Hartley to utilize a male Leur lock to further fortify the connection between the needle and the hub and lower the chances of undesired disconnection between the separate elements.
Claim(s) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2020/0197682) in view of Pecor et al. (USP #5,843,002).
As to claims 5 and 16, Franklin fails to teach a recessed gutter in the main body, wherein the recessed gutter is aligned with the side port and the one or more wire guides, and wherein the recessed gutter receives at least a portion of the guide wire. Franklin does teach the use of a guidewire clip that is configured to guide or secure the guidewire relative to the hub. Pecor teaches a gutter (58) aligned with a port to receive the receive a portion of the guide wire (Fig. 5). It would have been obvious to modify Franklin with Pecor to further secure the guidewire relative to the main body and prevent undesired movements of the guidewire relative to the main body.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2020/0197682) in view of Ornelas Vargas et al. (US 2017/0296792).
As to claim 7, Franklin fails to teach one or more rollers mounted to a top surface of the main body, wherein the one or more rollers assist with smooth advancement of the guide wire. Ornelas Vargas teaches the use of a roller (165) to aid the clinician in advancing or retracting the guidewire relative to the main body ([0066]). It would have been obvious to modify Franklin with Ornelas Vargas to ease the use of the device for the clinician.
Claim(s) 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2020/0197682) in view of Mangano et al. (US 2004/0030290).
As to claims 8 and 17, Franklin fails to teach the one or more wire guides comprise L-shaped wire guides. Mangano teaches the use of an L-shaped wire guide ([0026] - 24) to guide the guidewire. It would have been obvious to modify Franklin with Mangano to utilize a known shape for a wire guide known to guide direction of the guide wire as it would yield in substantially similar, and thus expected, results.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2020/0197682) in view of Duane et al. (US 2003/0191491).
As to claim 14, Franklin fails to teach a cheater attachment mounted to the side port to facilitate insertion of the guide wire. Duane teaches a catheter and guide wire system in which a cheater attachment is mounted to the side port to facilitate insertion of the guide wire (Fig. 14 - 164; [0057] - end 164 that is funnel-shaped to aid insertion of guide wire). It would have been obvious to modify Franklin with Duane to ease the use of the device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 10/28/25