DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 10 March 2026. The Examiner acknowledges the amendments to claims 1, 9, and 14, and the cancelation of claims 7, 12-13, and 18-20. Claims 1-6, 8-11, and 14-17 are pending.
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 .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-3, 5-6, and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harding (US-20210290264-A1, previously presented) in view of Koch (US-20110288533-A1).
Regarding claim 1, Harding teaches
A fluid transfer device for delivery of a probe to a patient's vascular system, the fluid transfer device comprising:
a housing [housing 104 (Harding Figs. 1A-B)];
a distal introducer portion positioned at a distal end portion of the housing and configured to penetrate a needleless access connector of a vascular access device [cannula 132 (Harding Figs. 1A-B, 3-8); the distal end 108 of the housing 104 may include the lever lock 130 to couple the housing 104 to the catheter assembly. The lever lock 130 may include a cannula 132 (Harding ¶0069); In some embodiments, in operation, the cannula 132 may penetrate a luer connector of the catheter assembly to access the fluid pathway of the catheter assembly (Harding ¶0070)];
a translation member movable relative to the housing, wherein the translation member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of movement of the translation member [advancement tab 112 (Harding Figs. 1A-B); In some embodiments, the advancement tab 112 may be configured to move linearly along the slot 110 between a retracted position 114 and an advanced position 116. In some embodiments, the advancement tab 112 may be coupled to a proximal end 120 of the instrument 102, such that moving the advancement tab 112 linearly along the slot 110 may cause the instrument 102 to move in a same direction as the advancement tab 112 relative to the housing 104 (Harding ¶0054)];
a connector member positioned proximate the distal introducer portion and configured for releasable connection to at least one surface of the needleless access connector, wherein the connector member comprises a pair of opposing distal clip portions and a pair of opposing proximal clip portions [at least two of the lever lock arms 128a, b (Harding Figs. 1A-B); In some embodiments, proximal ends of the lever lock arms 128a, b may be biased inwardly towards the longitudinal axis of the housing 104 to snap to or otherwise couple to the luer connector. In this manner, the lever lock arms 128a, b may automatically secure the cannula 132 to the luer connector. In some embodiments, the luer connector of the catheter assembly may include one or more recesses configured to receive one or more protrusions of the lever lock arms 128a, b. In some embodiments, the lever lock arms 128a, b may engage the protrusions of the lever lock arms 128a, b to secure the housing 104 to the catheter assembly (Harding ¶0070)]; and
a locking member, wherein the locking member is operably coupled to the translation member and is configured to prevent actuation of at least one of the pair of opposing proximal clip portions when the translation member is rotated to a first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the wheel member is rotated to a second position, with movement of the translation member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions [the lock element 900 may include a locking member 902 configured to interact with the lever lock arms 128a, b (Harding ¶0074, Figs. 9-10); in response to the instrument 102 being in the advanced position 116, the locking member 902 may be disposed in a locked position between the housing 104 and the lever lock arms 128a, b. In this position, the locking member 902 may prevent depression of the lever lock arms 128a, b and thus prevent release of the catheter assembly from the housing 104. In response to the instrument 102 being in the retracted position 114, the locking member 902 may be disposed proximal to the lever lock arms 128a, b in an unlocked position, thereby enabling the lever lock arms 128a, b to depress and to thus release the catheter assembly from the housing 104 (Harding ¶0075, Figs. 9-10)].
However, Harding fails to explicitly disclose wherein the translation member is a wheel member rotatable with respect to the housing, wherein the wherein the wheel member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member; wherein the locking member is operably coupled to the wheel member and is configured to prevent actuation of at least one of the pair of opposing proximal clip portions when the wheel member is rotated to a first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the wheel member is rotated to a second position, with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions.
Koch discloses a fluid transfer device for delivery of a probe to a patient's vascular system comprising a housing [elongated housing 11 (Koch Fig. 1)], distal introducer portion [Luer Lock extension 15 (Kock Fig. 1)], a wheel member rotatable with respect to the housing, wherein the wheel member is operable coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member [thumb wheel 25 (Koch Fig. 1); The threads on the thumb wheel engage with the grooves on the top surface of the traveller, such that rotating the thumb wheel in a distal direction causes the traveller to move in the proximal direction. In this case, tubular shaft member which is attached to the traveller is moved proximally and will expose the distal tip portion of the inner guidewire. Rotating the thumb wheel in an opposite, in this case proximal, direction causes the traveller to move in the distal direction. Here, tubular shaft member is moved distally on a longitudinal axis and will cause the distal tip portion of the inner guidewire to become enclosed by the tubular shaft member (Koch ¶0011); Traveller 16 moves within inner cavity 12, along the longitudinal axis of elongated housing 11. In a preferred embodiment, movement of traveller 16 in the longitudinal direction is accomplished by thumb wheel 25. In this embodiment, as seen in FIGS. 1 and 2, thumb wheel 25 has a threaded surface 31 and traveller 16 has a grooved upper surface 26. As thumb wheel 25 is rotated, the threaded surface 31 contacts with the grooved upper surface 26 of traveller 16 to cause longitudinal movement of traveller 16 within inner cavity 12 (Koch ¶0018); To control the distal tip 24 of inner guidewire 13, the tubular member 18 is moved in a proximal direction to allow exposure the distal tip 24 of inner guidewire 23. This is accomplished by rotating thumb wheel 25 in a distal direction, thereby causing traveller 16 to slide in a proximal direction (Koch ¶0021)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Harding to employ wherein the translation member is a wheel member rotatable with respect to the housing, wherein the wherein the wheel member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member, as this modification would amount to mere simple substitution of one known element for another with similar expected results [allow for translation of a probe] [MPEP § 2143(I)(B)]; and to have modified the device of Harding to employ wherein the locking member is operably coupled to the wheel member and is configured to prevent actuation of at least one of the pair of opposing proximal clip portions when the wheel member is rotated to a first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the wheel member is rotated to a second position, with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [rotation of a wheel member to cause linear actuation of elements operably coupled to rotation of the wheel member] [MPEP § 2143(I)(D)].
Regarding claim 2, Harding in view of Koch teaches
The fluid transfer device of claim 1, wherein the wheel member comprises a clocking member, and wherein the locking member is operably coupled to the clocking member [see § 103 modification of claim 1 above; A mechanism attached to the elongated housing member used to move the traveller in a longitudinal direction, such as a threaded thumb wheel, allows for movement of the traveller within the elongated housing. Movement of the traveller causes the attached tubular shaft member to move longitudinally (Koch ¶0010, Fig. 1), wherein the thumb wheel defining grooves to interface with grooves of traveller is considered to define a “clocking” member as described in the Applicant’s Specification ¶0079].
Regarding claim 3, Harding in view of Koch teaches
The fluid transfer device of claim 2, wherein the locking member comprises an arm coupled to the clocking member [elongated extension member 904 (Harding Figs. 9-10)].
Regarding claim 5, Harding in view of Koch teaches
The fluid transfer device of claim 1, wherein the locking member comprises a ring member longitudinally slidable over at least a portion of the housing [wherein as depicted in Figs. 9-10 of Harding, the locking member 902 is formed as part of a lock element 900 that is formed as a ring around the coupler element 122].
Regarding claim 6, Harding in view of Koch teaches
The fluid transfer device of claim 1, wherein the locking member comprises a biasing member configured to bias the locking member in one direction [In some embodiments, the lock element 900 may include a biasing element, such as a spring, or a cam element, such as a cam and follower, disposed within the housing 104 and automatically actuated in response to the advancement tab 112 moving in a distal direction beyond the retracted position 114. The biasing element or cam element may automatically activate the lock element 900 to lock the coupler element 122 and thereby prevent disengagement of the catheter assembly from the housing 104 (Harding ¶0076)].
Regarding claim 14, Harding teaches
A fluid transfer device for needle-free delivery of a probe to a patient’s vascular system, the fluid transfer device comprising:
a housing [housing 104 (Harding Figs. 1A-B)];
a distal introducer portion positioned at a distal end portion of the housing and configured to penetrate a needleless access connector for a vascular access device [cannula 132 (Harding Figs. 1A-B, 3-8); the distal end 108 of the housing 104 may include the lever lock 130 to couple the housing 104 to the catheter assembly. The lever lock 130 may include a cannula 132 (Harding ¶0069); In some embodiments, in operation, the cannula 132 may penetrate a luer connector of the catheter assembly to access the fluid pathway of the catheter assembly (Harding ¶0070)];
a translation member movable with respect to the housing, wherein the translation member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of movement of the translation member [advancement tab 112 (Harding Figs. 1A-B); In some embodiments, the advancement tab 112 may be configured to move linearly along the slot 110 between a retracted position 114 and an advanced position 116. In some embodiments, the advancement tab 112 may be coupled to a proximal end 120 of the instrument 102, such that moving the advancement tab 112 linearly along the slot 110 may cause the instrument 102 to move in a same direction as the advancement tab 112 relative to the housing 104 (Harding ¶0054)];
a connector member positioned proximate the distal introducer portion and configured for releasable connection to at least one surface of the needleless access connector [at least two of the lever lock arms 128a, b (Harding Figs. 1A-B); In some embodiments, proximal ends of the lever lock arms 128a, b may be biased inwardly towards the longitudinal axis of the housing 104 to snap to or otherwise couple to the luer connector. In this manner, the lever lock arms 128a, b may automatically secure the cannula 132 to the luer connector. In some embodiments, the luer connector of the catheter assembly may include one or more recesses configured to receive one or more protrusions of the lever lock arms 128a, b. In some embodiments, the lever lock arms 128a, b may engage the protrusions of the lever lock arms 128a, b to secure the housing 104 to the catheter assembly (Harding ¶0070)]; and
a locking member, wherein the locking member is configured to prevent disconnection of the connector member from the needleless access connector when the translation member is moved to a first position and to allow disconnection of the connector member when the translation member is moved to a second position, with movement of the translation member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions [the lock element 900 may include a locking member 902 configured to interact with the lever lock arms 128a, b (Harding ¶0074, Figs. 9-10); in response to the instrument 102 being in the advanced position 116, the locking member 902 may be disposed in a locked position between the housing 104 and the lever lock arms 128a, b. In this position, the locking member 902 may prevent depression of the lever lock arms 128a, b and thus prevent release of the catheter assembly from the housing 104. In response to the instrument 102 being in the retracted position 114, the locking member 902 may be disposed proximal to the lever lock arms 128a, b in an unlocked position, thereby enabling the lever lock arms 128a, b to depress and to thus release the catheter assembly from the housing 104 (Harding ¶0075, Figs. 9-10)].
However, Harding fails to explicitly disclose wherein the translation member is a wheel member rotatable with respect to the housing, wherein the wheel member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member; wherein the locking member is configured to prevent disconnection of the connector member from the needleless access connector when the wheel member is rotated to a first position and to allow disconnection of the connector member when the wheel member is rotated to a second position, with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions.
Koch discloses a fluid transfer device for delivery of a probe to a patient's vascular system comprising a housing [elongated housing 11 (Koch Fig. 1)], distal introducer portion [Luer Lock extension 15 (Kock Fig. 1)], a wheel member rotatable with respect to the housing, wherein the wheel member is operable coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member [thumb wheel 25 (Koch Fig. 1); The threads on the thumb wheel engage with the grooves on the top surface of the traveller, such that rotating the thumb wheel in a distal direction causes the traveller to move in the proximal direction. In this case, tubular shaft member which is attached to the traveller is moved proximally and will expose the distal tip portion of the inner guidewire. Rotating the thumb wheel in an opposite, in this case proximal, direction causes the traveller to move in the distal direction. Here, tubular shaft member is moved distally on a longitudinal axis and will cause the distal tip portion of the inner guidewire to become enclosed by the tubular shaft member (Koch ¶0011); Traveller 16 moves within inner cavity 12, along the longitudinal axis of elongated housing 11. In a preferred embodiment, movement of traveller 16 in the longitudinal direction is accomplished by thumb wheel 25. In this embodiment, as seen in FIGS. 1 and 2, thumb wheel 25 has a threaded surface 31 and traveller 16 has a grooved upper surface 26. As thumb wheel 25 is rotated, the threaded surface 31 contacts with the grooved upper surface 26 of traveller 16 to cause longitudinal movement of traveller 16 within inner cavity 12 (Koch ¶0018); To control the distal tip 24 of inner guidewire 13, the tubular member 18 is moved in a proximal direction to allow exposure the distal tip 24 of inner guidewire 23. This is accomplished by rotating thumb wheel 25 in a distal direction, thereby causing traveller 16 to slide in a proximal direction (Koch ¶0021)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Harding to employ wherein the translation member is a wheel member rotatable with respect to the housing, wherein the wheel member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member, as this modification would amount to mere simple substitution of one known element for another with similar expected results [allow for translation of a probe] [MPEP § 2143(I)(B)]; and to have modified the device of Harding to employ wherein the locking member is configured to prevent disconnection of the connector member from the needleless access connector when the wheel member is rotated to a first position and to allow disconnection of the connector member when the wheel member is rotated to a second position, with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [rotation of a wheel member to cause linear actuation of elements operably coupled to rotation of the wheel member] [MPEP § 2143(I)(D)].
Regarding claim 15, Harding in view of Koch teaches
The fluid transfer device of claim 14, wherein the locking member comprises a sleeve member [wherein as depicted in Figs. 9-10 of Harding, the locking member 902 is formed as part of a lock element 900 that is formed as a ring around the coupler element 122].
Regarding claim 16, Harding in view of Koch teaches
The fluid transfer device of claim 15, wherein the sleeve member is configured to extend over at least a portion of the connector member when the wheel member is rotated to the first position [wherein as depicted in Figs. 9-10 of Harding, the locking member 902 is formed as part of a lock element 900 that is formed as a ring around the coupler element 122].
Regarding claim 17, Harding in view of Koch teaches
The fluid transfer device of claim 14, wherein at least a portion of the locking member is configured to extend under at least a portion of the connector member when the wheel member is in the first position [Harding ¶¶0074-0075, Figs. 9-10].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harding in view of Koch, as applied to claim 3 above, in further view of Tegg (US-20150196736-A1, previously presented).
Regarding claim 4, Harding in view of Koch teaches
The fluid transfer device of claim 3.
However, Harding in view of Koch fails to explicitly disclose wherein one end of the arm comprises a post configured to ride within a cam groove formed in the clocking member.
Harding does disclose the use of a cam element, including a cam and follower [Harding ¶0076].
Tegg discloses a catheter device, wherein Tegg discloses the use of a wheel member, wherein an arm comprises a post configured to ride within a cam groove formed in the wheel member [the distal end of the first cam arm is pivotably mounted to a first pin block 72 by a first pivot pin 74… The first pin block 72 is attached to (or comprises an integral part of) a pivotable base 80 that rotates relative to the channeled platform 50 (Tegg ¶0035, Fig. 3); FIG. 7 is a top or plan view, depicting components of the deflection actuator 12 mounted in the lower handle housing 16, and with the deflection actuator fully actuated in a first direction. In this configuration, the first cam arm 42 is displaced as far as possible toward the proximal end 18 of the lower handle housing 16 (Tegg ¶0039, Fig. 7)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Harding in view of Koch to employ wherein one end of the arm comprises a post configured to ride within a cam groove formed in the clocking member, as this modification would amount to merely applying a known technique [cam groove within a rotatable member to move a cam arm] to a known device ready for improvement to yield predictable results [translate rotation of a wheel member to linear actuation of an operably coupled post] [MPEP § 2143(I)(D)].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harding in view of Koch, as applied to claim 1 above, in further view of Cummins (US-20160074184-A1, previously presented).
Regarding claim 8, Harding in view of Koch teaches
The fluid transfer device of claim 1, wherein the locking member comprises at least one tab [locking member 902 (Harding ¶0074, Figs. 9-10)].
However, Harding in view of Koch fails to explicitly disclose wherein the at least one tab is displaceable by a wire operably coupled to the wheel member.
Cummins discloses a vascular intervention device delivery system, wherein Cummins discloses a wheel member configured to displace a wire coupled to the wheel member [Pull 38 may comprise a metallic wire or thin band of metal (Cummins ¶0016); the user then grips handle 11 and begins to rotate thumbwheel 15 so that pull 38 is wound onto spool 17. As this occurs, pull 38 and retractable sheath 37 move proximally with respect to catheter 30 (Cummins ¶0018)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Harding in view of Koch to employ wherein the at least one tab is displaceable by a wire operably coupled to the wheel member, as this modification would amount to mere simple substitution of one known element [arm (elongated extension member 904 of Harding)] for another [wire (pull 38 of Cummins)] with similar expected results [operably coupling movement of one element to another] [MPEP § 2143(I)(B)].
Claim(s) 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US-20210052851-A1, previously presented) in view of Harding (US-20210290264-A1, previously presented) and Tegg (US-20150196736-A1, previously presented).
Regarding claim 9, Devgon teaches
A fluid transfer device for delivery of a probe to a patient's vascular system, the fluid transfer device comprising:
a housing [housing 610 (Devgon Figs. 11-13)];
a distal introducer portion positioned at a distal end portion of the housing and configured to penetrate a needleless access connector of a vascular access device [The housing 610 includes… a second port 612 configured to movably receive a distal end portion 632 of the catheter 630. The ports 611 and 612 can be any suitable configuration such as any of those described above (Devgon ¶0094, Figs. 11-13); the second port 112 can be a lock mechanism and/or coupler configured to couple the housing 110 to a PIV (e.g., an indwelling or placed PIV) and/or any suitable adapter coupled to a PIV (e.g., an IV extension set or the like). For example, in some embodiments, the second port 112 can be a Luer Lok™, a “Clip-Lock-Snap” connection, and/or the like configured to physically and fluidically couple to, for example, the PIV (Devgon ¶0045); While the second port 112 is described as being configured to couple to a PIV, it should be understood that the second port 112 can be configured to couple to any suitable connector, adapter, access device, and/or any other suitable device. Moreover, as described above, the PIV can be a standard or short PIV, an extended-dwell PIV, a midline PIV, a PICC line, and/or the like (Devgon ¶0046); see also Annotated Fig. 1];
a wheel member rotatable with respect to the housing, wherein the wheel member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member [actuator 650 (Devgon Figs. 11-13), wherein as depicted in Figs. 11-13, the actuator 650 is considered to define a wheel; As described above, the catheter 630 or a portion thereof can be moved (e.g., via rotational movement of the actuator 650) between the first position (FIGS. 11 and 12), in which the distal end portion 632 of the catheter 630 is disposed within the housing 610 and/or the second port 612, and a second position (FIG. 13), in which at least a portion of the catheter 630 extends through the second port 612 and at least a portion of an access device coupled to the second port 612 (Devgon ¶0097); The actuator 650 can be coupled to the housing 610 in any suitable manner that allows the actuator 650 to be rotated relative to the housing 610. Moreover, the actuator 650 can be coupled to the housing 610 such that the second portion 652 is at least partially disposed within the housing 610 and in contact with and/or otherwise allowed to engage the catheter 630. In this manner, the actuator 650 can be substantially similar in at least form and/or function to the actuator 250 described above with reference to FIGS. 3 and 4 (Devgon ¶0098)];
a connector member positioned proximate the distal introducer portion and configured for releasable connection to at least one surface of the needleless access connector, wherein the connector member comprises a pair of opposing distal clip portions and a pair of opposing proximal clip portions [second port 612 (Devgon Figs. 11-13); For example, in some embodiments, a user can manipulate the fluid transfer device to physically and fluidically couple the second port of the housing of the fluid transfer device to an indwelling vascular access device such as an indwelling peripheral intravenous line (NV), and extended-dwell PIV, a midline PIV, a PICC line and/or the like. The arrangement of the catheter of the fluid transfer device can be such that the proximal end portion of the catheter is fixedly coupled to and/or otherwise maintained in a fixed position relative to the first port. In some embodiments, the second port of the housing can be and/or can include a Luer Lok™, a “Clip-Lock-Snap” connection, and/or the like configured to physically and fluidically couple to, for example, the PIV (Devgon ¶0180); see Annotated Fig. 1].
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Annotated Fig. 1. The Examiner has annotated Fig. 11 of Devgon to identify the portions of second port 612 [connector member] that are considered to specifically comprise each of the claimed “distal introducer portion”, “pair of opposing distal clip portions”, and “pair of opposing proximal clip portions”.
However Devgon fails to explicitly disclose a locking member, wherein the locking member is operably coupled to the wheel member and is configured to prevent actuation of at least one of the pair of opposing proximal clip portions when the wheel member is rotated to a first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the wheel member is rotated to a second position, wherein the locking member comprises at least one proximal arm member.
Harding discloses a fluid transfer device for delivery of a probe to a patient's vascular system comprising a housing [housing 104 (Harding ¶0074)], distal introducer portion [cannula 132 (Harding Figs. 9-10)], an advancement member operably coupled to the probe to advance/retract the probe [advancement tab 112; the advancement tab 112 may be configured to move linearly along the slot 110 between a retracted position 114 and an advanced position 116. In some embodiments, the advancement tab 112 may be coupled to a proximal end 120 of the instrument 102, such that moving the advancement tab 112 linearly along the slot 110 may cause the instrument 102 to move in a same direction as the advancement tab 112 relative to the housing 104 (Harding ¶0054, Figs. 9-10)], and a connector member comprising a pair of opposing distal clip portions and a pair of opposing proximal clip portions [the distal end 108 of the housing 104 may include the lever lock 130 to couple the housing 104 to the catheter assembly. The lever lock 130 may include a cannula 132 and at least two of the lever lock arms 128a, b (Harding ¶0069, Figs. 9-10)]; wherein Harding discloses a locking member, wherein the locking member is operably coupled to the advancement member and is configured to prevent actuation of at least one of the pair of opposing proximal clip portions when the advancement member is advanced to a first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the advancement member is retracted to a second position [the lock element 900 may include a locking member 902 configured to interact with the lever lock arms 128a, b (Harding ¶0074, Figs. 9-10); in response to the instrument 102 being in the advanced position 116, the locking member 902 may be disposed in a locked position between the housing 104 and the lever lock arms 128a, b. In this position, the locking member 902 may prevent depression of the lever lock arms 128a, b and thus prevent release of the catheter assembly from the housing 104. In response to the instrument 102 being in the retracted position 114, the locking member 902 may be disposed proximal to the lever lock arms 128a, b in an unlocked position, thereby enabling the lever lock arms 128a, b to depress and to thus release the catheter assembly from the housing 104 (Harding ¶0075, Figs. 9-10), wherein the Examiner notes that the advancement tab 112 of Harding is considered to function similarly to the actuator 650 (wheel member) as disclosed by Devgon, as both the advancement tab 112 of Harding and actuator 650 of Devgon are operably coupled to a probe/instrument such that movement of advancement tab 112/actuator 650 is configured to advance or retract the probe/instrument].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Devgon to employ a locking member, wherein the locking member is operably coupled to the wheel member and is configured to prevent actuation of at least one of the pair of opposing proximal clip portions when the wheel member is rotated to a first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the wheel member is rotated to a second position, so as to prevent inadvertent release of the needleless access connector from the connector member while the probe is in an advanced position.
However, Devgon in view of Harding fails to explicitly disclose wherein the wheel member comprises at least one slot provided on a radial surface of the wheel member, wherein the at least one slot is sized and configured to accommodate at least a portion of the at least one proximal arm member.
Tegg discloses a catheter device, wherein Tegg discloses the use of a wheel member, wherein the wheel member comprises at least one slot provided on a radial surface of the wheel member, wherein the at least one slot is sized and configured to accommodate at least a portion of at least one proximal arm member [Tegg ¶¶0035, 0039, Figs. 3, 7, 9; wherein as depicted in Fig. 9 of Tegg, the pivotable base 80 (wheel member of Tegg) comprises a slot on a radial surface for interfacing with first cam arm 42].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Devgon in view of Harding to employ wherein the wheel member comprises at least one slot provided on a radial surface of the wheel member, wherein the at least one slot is sized and configured to accommodate at least a portion of the at least one proximal arm member, as this modification would amount to merely applying a known technique [slot along a radial surface of a wheel member to translate rotation of the wheel member to movement of an arm] to a known device ready for improvement to yield predictable results [translate rotation of a wheel member to linear actuation of an operably coupled post] [MPEP § 2143(I)(D)].
Regarding claim 11, Devgon in view of Harding and Tegg teaches
The fluid transfer device of claim 9.
However, Devgon in view of Harding and Tegg as presently modified fails to explicitly disclose wherein the locking member further comprises a ramped distal member.
Harding is considered to depict a rectangular distal member interfacing with a ramped end of a proximal clip portion to prevent depression of the proximal clip portion [see Annotated Fig. 2].
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Annotated Fig. 2. The Examiner has annotated Fig. 10A of Harding to identify the use of a rectangular distal member of the locking member interfacing with a ramped end of the proximal clip portion of Harding.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Devgon in view of Harding and Tegg to employ wherein the locking member further comprises a ramped distal member, as this modification would amount to mere simple substitution of one known element for another [rectangular distal member of the locking member to interface with a ramped end portion of the proximal clip portion to be substituted for a ramped distal member of the locking member to interface with a rectangular end portion of the proximal clip portion] with similar expected results [physically engage elements] [MPEP § 2143(I)(B)].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Harding and Tegg, as applied to claim 9 above, in further view of Ferguson (US-20010039401-A1, previously presented).
Regarding claim 10, Devgon in view of Harding and Tegg teaches
The fluid transfer device of claim 9.
However, Devgon in view of Harding and Tegg fails to explicitly disclose wherein the locking member further comprises at least one living hinge coupled to at least one of the pair of opposing proximal clip portions on a first end and to the at least one proximal arm member on a second end.
Tegg does disclose wherein the portion of the at least one proximal arm member is configured to interface with at least one distal arm member to linearly translate the at least one distal arm member [A first cam arm 42 may be seen in FIG. 2. In particular, the first cam arm 42 is shown with its proximal end (also known as an arcuate pushing end 108, which is labeled in FIG. 6) pressing against a distal end (also known as a slider pushed end 110, which is labeled in FIG. 6) of a first slider 44 that is longitudinally slidably mounted in a first slider trough or slider guide channel 46 (Tegg ¶0033); As shown to good advantage in FIG. 6, the proximal end of the first cam arm 42 includes a first arcuate pushing end 108 adapted to push against a first slider pushed end 110 (Tegg ¶0038, Fig. 6), wherein the slider 44 may define a first end/distal arm member, and as previously noted the first cam arm 42 may define a second end/proximal arm member].
Ferguson discloses a fluid transfer device that includes a proximal arm coupled to a distal arm via a living hinge, such that a force applied to the proximal arm is translated to the distal arm [The shield 22 is manually extended and locked in a single-handed manner following use by either: 1) pushing the shield 22 with a finger, for example at raised surface 56 (FIG. 9); or 2) surface activation by, for example, pushing the shield 22 against a surface such as a tabletop. Referring to FIGS. 1-3, surface activation is enabled due to the configuration of shield 22 such that proximal segment 12 and distal segment 14 form a general fulcrum point 13 engageable to extend shield 22 to the extended position. Fulcrum 13 includes a hinge portion projecting from shield 22 that engages the table, etc. It is contemplated that fulcrum 13 may include hinge portions, such as, for example, living hinges, pinned hinges, etc. (Ferguson ¶0090, Figs. 1, 3-4)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Devgon in view of Harding and Tegg to employ wherein the locking member further comprises at least one living hinge coupled to at least one of the pair of opposing proximal clip portions on a first end and to the at least one proximal arm member on a second end, so as to facilitate translation of the position of the wheel member to the locking position of the locking member to prevent actuation of the proximal clip portions to prevent inadvertent release of the connector member, and may further be considered mere application of a known technique [living hinge] to a known device [coupled proximal and distal arms/coupled first and second arm members] ready for improvement to yield predictable results [translate movement of one arm to another arm] [MPEP § 2143(I)(D)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 10 March 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections for the same reference character being used to refer to different elements and for a missing arrow for a reference character have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-13, with respect to the rejection(s) of claim(s) 1, 14, and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Harding (US-20210290264-A1, previously presented) in view of Koch (US-20110288533-A1).
Regarding claims 1 and 14, the Applicant asserts that the previously applied Devgon in view of Harding teaches or suggests amended claims 1 and 14 regarding a locking member, wherein the locking member is configured to prevent disconnection of the connector member from the needleless access connector when the wheel member is rotated to a first position and to allow disconnection of the connector member when the wheel member is rotated to a second position, with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions, as the Applicant notes that there is no mechanism/means taught or suggested in Harding by which rotational movement/actuation of an advancement tab/wheel is translated into a distal linear movement of locking member 902 to a position that prevents actuation of the lever lock arms 128a, b. The Examiner notes that Applicant’s arguments with respect to claim(s) 1 and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Harding (US-20210290264-A1, previously presented) is presently modified in view of Koch (US-20110288533-A1), as the Examiner notes that Koch discloses a mechanism/means by which rotational movement/actuation of an advancement tab/wheel is translated into a distal linear movement of at least a probe coupled to the advancement tab/wheel [The threads on the thumb wheel engage with the grooves on the top surface of the traveller, such that rotating the thumb wheel in a distal direction causes the traveller to move in the proximal direction. In this case, tubular shaft member which is attached to the traveller is moved proximally and will expose the distal tip portion of the inner guidewire. Rotating the thumb wheel in an opposite, in this case proximal, direction causes the traveller to move in the distal direction. Here, tubular shaft member is moved distally on a longitudinal axis and will cause the distal tip portion of the inner guidewire to become enclosed by the tubular shaft member (Koch ¶0011); Traveller 16 moves within inner cavity 12, along the longitudinal axis of elongated housing 11. In a preferred embodiment, movement of traveller 16 in the longitudinal direction is accomplished by thumb wheel 25. In this embodiment, as seen in FIGS. 1 and 2, thumb wheel 25 has a threaded surface 31 and traveller 16 has a grooved upper surface 26. As thumb wheel 25 is rotated, the threaded surface 31 contacts with the grooved upper surface 26 of traveller 16 to cause longitudinal movement of traveller 16 within inner cavity 12 (Koch ¶0018); To control the distal tip 24 of inner guidewire 13, the tubular member 18 is moved in a proximal direction to allow exposure the distal tip 24 of inner guidewire 23. This is accomplished by rotating thumb wheel 25 in a distal direction, thereby causing traveller 16 to slide in a proximal direction (Koch ¶0021)], such that in light of the disclosure of a locking member as taught by Harding [the lock element 900 may include a locking member 902 configured to interact with the lever lock arms 128a, b (Harding ¶¶0074-0075, Figs. 9-10)], the combination of Harding in view of Koch is considered to render obvious the amended limitation.
Applicant's arguments, see Applicant’s Remarks p. 7-13, with respect rejection(s) of claim(s) 9 and those dependent therefrom under § 103 have been fully considered but they are not persuasive.
Regarding claim 9, the Applicant asserts that Devgon, Harding, and Tegg, as combined, fails to teach or suggest a fluid transfer device that includes a wheel member and locking member as claimed, where the locking member comprises “at least one proximal arm member, and wherein the wheel member comprises at least one slot provided on a radial surface of the wheel member, wherein the at least one slot is sized and configured to accommodate at least a portion of the at least one proximal arm member”, wherein the Applicant asserts that the Examiner proposed combination of Devgon, Harding, and Tegg would not be obvious to one skilled in the art and that the combination appears to be the product of impermissible hindsight, as the Applicant notes that Tegg discloses a catheter deflection apparatus, while Harding and Devgon are directed to fluid transfer and/or vascular access devices, such that there is no motivation to modify the fluid transfer and/or vascular access devices of Devgon and Harding in view of the catheter deflection apparatus of Tegg. However, the Examiner disagrees with the Applicant’s argument that Devgon/Harding and Tegg are directed towards different fields of endeavor, in response to applicant’s argument that Tegg is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Tegg is considered to be in a similar field of endeavor, as Tegg is directed towards systems and methods for delivery of a probe to a patient’s vascular system [Typically, a catheter is deployed and manipulated through a patient's vasculature to the intended site, for example, a site within the patient's heart (Tegg ¶0006); In order to facilitate the advancement of catheters through a patient's vasculature, the simultaneous application of torque at the proximal end of the catheter and the ability to selectively deflect the distal tip of the catheter in a desired direction can permit medical personnel to adjust the direction of advancement of the distal end of the catheter and to selectively position the distal portion of the catheter during an electrophysiological procedure. The proximal end of the catheter can be manipulated to guide the catheter through a patient's vasculature. The distal tip can be deflected by a tension member attached at the distal end of the catheter and extending proximally to an actuator in a control handle that controls the application of tension on the tension member (Tegg ¶0008); The foregoing discussion is intended only to illustrate the present field and should not be taken as a disavowal of claim scope (Tegg ¶0009)], such that Tegg is considered to relevant and applicable. As such, as Tegg is considered to disclose known/relevant mechanisms/means for translating rotation of a wheel to distal/proximal advancement of elements operably coupled to the wheel, the modification of Devgon in view of Harding based on the disclosure of Tegg is considered applicable.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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