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 .
Response to Amendment
The amendment filed January 14, 2026 in response to the Office Action of October 21, 2025 has been acknowledged and entered.
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.
Claims 1-2, 4, 7-8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 20170216564) (previously cited) in view of Harding (US 20210290264) (previously cited) (cited by Applicant).
Regarding claim 1, Devgon teaches a fluid transfer device for delivery of a probe (260) to a patient's vascular system, (Figs. 3-5) the fluid transfer device comprising: an introducer body (210); a distal introducer portion (Fig. 14, tip of proboscis 242) positioned at a distal end portion of the introducer body and configured to penetrate an access connector of a vascular access device (Paragraph [0074]); an actuator (270), wherein the actuator is linearly displaceable along at least a portion of the introducer body, and wherein the actuator is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of displacement of the actuator (Paragraphs [0072], [0086]); a connector member (proboscis 242) positioned proximate the distal introducer portion (Fig. 14, tip of proboscis 242) and configured for releasable connection to at least one surface of the access connector, (Paragraphs [0074], [0114]), to draw the blood sample, the user attaches a transfer device to a port and/or suitable portion of the extension set), wherein the connector member comprises a pair of opposing distal clip portions (245) and a pair of opposing proximal clip portions (244);
However, Devgon does not teach “a locking member, wherein the locking member is linearly displaceable along at least a portion of the introducer body and is configured to prevent actuation of at least one of the pair of opposing proximal clip portions when the actuator is displaced at least partially toward first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the actuator is displaced at least partially toward a second position.”
Harding, in a related field of endeavor, teaches a vascular access device (Figs. 9A-10B) comprising a locking member (902), wherein the locking member is linearly displaceable along at least a portion of the introducer body (Paragraph [0074]) and is configured to prevent actuation of at least one of the pair of opposing proximal clip portions (128a, b) when the actuator is displaced at least partially toward first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the actuator is displaced at least partially toward a second position. (Paragraphs [0074]-[0075]).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vascular device of Devgon to include “a locking member, wherein the locking member is linearly displaceable along at least a portion of the introducer body and is configured to prevent actuation of at least one of the pair of opposing proximal clip portions when the actuator is displaced at least partially toward first position and to allow actuation of at least one of the pair of opposing proximal clip portions when the actuator is displaced at least partially toward a second position” as taught by Harding. Doing so may prevent depression of the lever lock arms and thus prevent release of the catheter assembly from the housing. (Paragraph [0075]).
Regarding claim 2, Devgon does not teach “wherein the locking member comprises a single locking arm member, and wherein the single locking arm member is configured to block actuation of a single one of the pair of opposing proximal clip portions of the connector member.”
Harding, as discussed above, teaches wherein the locking member (902) comprises a single locking arm member, (See Fig. 10A, 10B), and wherein the single locking arm member is configured to block actuation of a single one of the pair of opposing proximal clip portions (128a) of the connector member (122).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vascular device of Devgon to include “wherein the locking member comprises a single locking arm member, and wherein the single locking arm member is configured to block actuation of a single one of the pair of opposing proximal clip portions of the connector member” as taught by Harding. Doing so may prevent depression of the lever lock arms and thus prevent release of the catheter assembly from the housing. (Paragraph [0075]).
Regarding claim 4, Devgon does not teach “wherein the locking member comprises a pair of opposing arm members, and wherein the pair of opposing arm members are configured to block actuation of the pair of opposing proximal clip portions of the connector member.”
Harding teaches wherein the locking member (902) comprises a pair of opposing arm members, (See Fig. 10A, 10B) and wherein the pair of opposing arm members are configured to block actuation of the pair of opposing proximal clip portions (128a, b) of the connector member (122).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vascular device of Devgon to include “wherein the locking member comprises a pair of opposing arm members, and wherein the pair of opposing arm members are configured to block actuation of the pair of opposing proximal clip portions of the connector member” as taught by Harding. Doing so may prevent depression of the lever lock arms and thus prevent release of the catheter assembly from the housing. (Paragraph [0075]).Regarding claim 7, Devgon does not teach “wherein the locking member comprises a biasing member configured to bias the locking member in one direction.”
Harding teaches wherein the locking member comprises a biasing member (i.e., spring, cam element) configured to bias the locking member in one direction. (Paragraphs [0076]-[0077]).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vascular device of Devgon to include “wherein the locking member comprises a biasing member configured to bias the locking member in one direction” as taught by Harding. Doing so provides a mechanism that may automatically activate the
lock element to lock the coupler element and thereby prevent disengagement of the catheter assembly from the housing. (Paragraph [0076]).
Regarding claim 7, Devgon does not teach “wherein the locking member comprises a biasing member configured to bias the locking member in one direction.”
Harding teaches wherein the locking member comprises a biasing member (i.e., spring, cam element) configured to bias the locking member in one direction. (Paragraphs [0076]-[0077]).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vascular device of Devgon to include “wherein the locking member comprises a biasing member configured to bias the locking member in one direction” as taught by Harding. Doing so provides a mechanism that may automatically activate the
lock element to lock the coupler element and thereby prevent disengagement of the catheter assembly from the housing. (Paragraph [0076]).
Regarding claim 8, Devgon does not teach “a holding tab, wherein the holding tab is configured to hold the locking member proximally away from the connector member.”
Harding teaches a holding tab, wherein the holding tab (112) is configured to hold the locking member (902) proximally away from the connector member (122). (Paragraph [0076]).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vascular device of Devgon to include “a holding tab, wherein the holding tab is configured to hold the locking member proximally away from the connector member” as taught by Harding. Doing so controls the locking member such that the lever lock arms may be kept unlocked, which may prevent a user from removing the instrument from the catheter assembly when the advancement tab is in any position except its most proximal and retracted position. (Paragraphs [0078]).
Regarding claim 12, Devgon does not teach “wherein the locking member is manually displaceable by a user”.
Harding teaches wherein the locking member (902) is manually displaceable by a user (via advancement tab 112). (Paragraph [0077]-[0078]).
As a result, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vascular device of Devgon to include “wherein the locking member is manually displaceable by a user” as taught by Harding. Doing so provides greater control of the locking member, whereby a clinician may easily pinch or grasp the advancement tab to move the instrument between the retracted position and the advanced position (Paragraphs [0054], [0078]).
Allowable Subject Matter
Claims 3 and 5-6 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 13-15 and 17-23 are allowed.
Regarding claim 3, Devgon does not teach “wherein the single locking arm member extends distally from a base portion, and wherein the base portion is configured to be slidable along at least a portion of the introducer body with the base portion configured to couple to the actuator when the actuator is moved distally into contact with the locking member, such that upon the locking portion coupling to the actuator, the locking member is simultaneously pulled proximally away from the connector member when the actuator is retracted from the second position back toward the first position.”
Harding teaches (Figs. 9A-9B) wherein the single locking arm member (902) extends distally from a base portion, and wherein the base portion is configured to be slidable along at least a portion of the introducer body (104). (Paragraphs [0076]-[0077]).
However, Devgon as modified by Harding does not teach “with the base portion configured to couple to the actuator when the actuator is moved distally into contact with the locking member, such that upon the locking portion coupling to the actuator, the locking member is simultaneously pulled proximally away from the connector member when the actuator is retracted from the second position back toward the first position.”
Regarding claim 5, Devgon does not teach “wherein the pair of opposing arm members extend distally from a base portion, and wherein the base portion is configured to be slidable along at least a portion of the introducer body, with the base portion configured to couple to the actuator when the actuator is moved distally into contact with the locking member, such that upon the locking portion coupling to the actuator, the locking member is simultaneously pulled proximally away from the connector member when the actuator is retracted from the second position back toward the first position.”
Harding teaches (Figs. 9A-9B) wherein the pair of opposing arm members (902) extend distally from a base portion (900), and wherein the base portion is configured to be slidable along at least a portion of the introducer body (104). (Paragraphs [0076]-[0077]).
However, Devgon as modified by Harding does not teach “with the base portion configured to couple to the actuator when the actuator is moved distally into contact with the locking member, such that upon the locking portion coupling to the actuator, the locking member is simultaneously pulled proximally away from the connector member when the actuator is retracted from the second position back toward the first position.”
Claim 6 is allowable by virtue of its dependence from claim 5.
Regarding claim 13, Devgon teaches a fluid transfer device for needle-free delivery of a probe (260) to a patient's vascular system, (Figs. 3-5), the fluid transfer device comprising: an introducer body (210) having a distal end portion and a proximal end portion; an actuator (270), wherein the actuator is linearly displaceable along at least a portion of the introducer body, and wherein the actuator is operably coupled to the probe to advance and retract the probe based on direction of displacement of the actuator (Paragraphs [0072], [0086]); a connector member (proboscis 242) positioned proximate the distal end portion of the introducer body (Fig. 14, tip of proboscis 242) and configured for releasable connection to at least one surface of an access connector (Paragraphs [0074], [0114]).
However, Devgon does not teach “a locking member, wherein the locking member is configured to prevent disconnection of the connector member from the access connector when the actuator is advanced to a first position along the introducer body and to allow disconnection of the connector member when the actuator is retracted to a second position along the introducer body; wherein the locking member comprises a base portion and one or more locking arm members extending distally from the base portion; and wherein the base portion is configured to couple to the actuator when the actuator is moved distally into contact with the locking member, such that upon the locking portion coupling to the actuator, the locking member is simultaneously pulled proximally away from the connector member when the actuator is retracted from the second position back toward the first position.”
Harding teaches a vascular access device (Figs. 9A-10B) comprising a locking member (902), wherein the locking member is configured to prevent disconnection of the connector member from the access connector when the actuator (advancement tab 112) is advanced to a first position along the introducer body (Paragraph [0075] in the locked position, locking member 902 may prevent release of the catheter assembly from the housing 104) and to allow disconnection of the connector member when the actuator (112) is retracted to a second position along the introducer body. (Paragraph [0075] in the unlocked position, locking member 902 may release of the catheter assembly from the housing 104); wherein the locking member (902) comprises a base portion (900) and one or more locking arm members extending distally from the base portion (Figs. 9A-9B).
However Harding does not teach “and wherein the base portion is configured to couple to the actuator when the actuator is moved distally into contact with the locking member, such that upon the locking portion coupling to the actuator, the locking member is simultaneously pulled proximally away from the connector member when the actuator is retracted from the second position back toward the first position”.
Claims 14-15, 17, and 22-23 are allowable by virtue of their dependence from claim 13.
Regarding claim 18, Devgon teaches a fluid transfer device for needle-free delivery of a probe (260) to a patient's vascular system, (Figs. 3-5), the fluid transfer device comprising: an introducer body (210) having a distal end portion and a proximal end portion; an actuator (270), wherein the actuator is linearly displaceable along at least a portion of the introducer body between a proximal first position and a distal second position, and wherein the actuator is operably coupled to the probe to advance and retract the probe based on direction of displacement of the actuator (Paragraphs [0072], [0086]); a connector member (proboscis 242) positioned proximate the distal end portion of the introducer body (Fig. 14, tip of proboscis 242) and configured for releasable connection to at least one surface of an access connector (Paragraphs [0074], [0114]);
However, Devgon does not teach “a locking member, wherein the locking member comprises: a base portion; at least one arm member and an elongated tether portion extending proximally from the at least one arm member, wherein the at least one arm member is configured to selectively block actuation of the connector member based upon the position of the actuator along the introducer body.”
Harding teaches a vascular access device (Fig. 9A) comprising a locking member (902), wherein the locking member comprises a base portion; at least one arm member (See Fig. 9A) and an elongated tether portion (elongated extension member 904) extending proximally from the at least one arm member, wherein the at least one arm member is configured to selectively block actuation of the connector member based upon the position of the actuator along the introducer body. (Paragraphs [0074]-[0075]).
However, Devgon does not teach “an elongated tether portion extending proximally from the at least one arm member; and a proximal tether member positioned at a proximal end of the elongated tether portion and proximal to the actuator; wherein the actuator is movable relative to the elongated tether portion, such that the actuator may be moved into contact with the base portion as the actuator is advanced distally from the first position toward the second position.”
Claims 19-21 are allowable by virtue of their dependence from claim 18.
Response to Arguments
Applicant's arguments filed 1/14/26 have been fully considered but they are not persuasive.
Applicant argues that Harding fails to teach or suggest a locking member that is "linearly displaceable along at least a portion of the introducer body," as recited in claim 1.
This is not persuasive.
As discussed in the Paragraphs [0076]-[0077] of Harding, the lock element 900 (i.e., the locking member 902 thereof) slides in response to distal movement of the advancement tab 112 - with the locking member 902 moving from an unlocked position on coupler element 122 (FIG. 9B) to a locked position on coupler element 122 (FIG. 10B). Hence, the locking member is "linearly displaceable along at least a portion of the introducer body”.
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/
Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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