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 on 10/17/25 has been entered in the case. Claims 1-20 are pending for examination.
Information Disclosure Statement
The information disclosure statement filed 07/25/25 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because: The US Patent No. 20140064766 is not related to the current invention. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 2012/0277627) in view of Godfrey (US 2010/0100049).
Regarding claim 1, Devgon discloses a fluid transfer device 6000, in Figs. 9-14 comprising:
an introducer 6100 having a proximal end portion 6120 and a distal end portion 6130, the introducer 6100 defining an inner volume configured to movably receive a catheter 6200, see Fig. 11;
a lock 6131/6411coupled to the distal end portion 6130 and configured to be coupled to an indwelling peripheral intravenous line 6300.
Devgon does not disclose that a support member coupled to the lock, the support member configured to dispose the fluid transfer device at a predetermined angle relative to a target surface, wherein the support member comprises an annular opening encircling at least a portion of the lock.
Godfrey discloses a securement device 14 comprising: a support member 14 coupled to a lock member 28; wherein the support member 14 configured to dispose a fluid transfer device 18 at a predetermined angle, i.e. inclined angle A relative to a target surface P, see Fig. 6; wherein the support member comprises an annular opening 48 (or/and 40) encircling at least a portion (at least ½ bottom portion) of the lock member 28.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Devgon with including a support member being coupled to a lock member, as taught by Godfrey, in order to support catheter and other vascular access device.
Regarding claim 2, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the predetermined angle is substantially equal to an angle of insertion of the peripheral intravenous line, see Fig. 6.
Regarding claim 3, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that the predetermined angle is between 0° and 30° (e.g. in this case, the predetermined angle A is about 3-5 degrees, para [0022].
Regarding claim 4, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that the predetermined angle is between 0° and 30° (e.g. in this case, the predetermined angle A is about 3-5 degrees. Meanwhile, the claimed invention requires that the predetermined angle is approximately 25°. It would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the predetermined angle about 25°, since it has been held that discovering an optimum value (in different direction or angle of insertion into a patient) of a result effective variable involves only routine skill in the art.
Regarding claim 5, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the support member 14 includes a first portion 40 configured to receive a portion of the lock 32 in Godrey (which is similar to the lock 6131/6411 in Devgon) therein and a second portion 36 & 38 configured to contact the target surface P.
Regarding claim 6, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the first portion 40 of the support member includes an annular opening 40 (or/and 48) extending along an axis (x-axis), and wherein at least a portion 33 of the second portion 36 & 38 (in y-axis) is substantially perpendicular to the axis (x-axis), see marked-up Fig. 4 below.
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Regarding claim 7, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the lock 28/32 includes a proboscis 27, and wherein the first portion of the support member 14 receives at least a portion of the proboscis therein, see Fig. 5. Therefore, Devgon in view of Godfrey discloses that wherein the first portion 40 of the support member 14 receives at least a portion of the proboscis, i.e., nose of the lock 6411.
Regarding claim 8, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the support member 14 is releasably attachable to the lock 28/32 (or the lock 6411/6131 in Devgon).
Regarding claim 9, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that a hub of the intravenous line 26 being inserted into the proboscis 27. Therefore, Godfrey discloses that wherein at least a portion 27 of the lock 28 is friction fit within the support member. In this case, a person skilled in the art would recognize that the hub of the intervenors line 6300 being inserted into the proboscis/nose of the lock 6400 and that considered as rearrangement parts. Thus, Devgon in view of Godfrey discloses that at least a proboscis portion (nose portion) of the lock 6411/6131 is friction fit within the support member 14 (as modified by Godfrey).
Regarding claim 10, Devgon in view of Godfrey discloses all the claimed subject matter as required. Devgon discloses that wherein the lock includes a first arm (a nose located inside the lock 6411) and a second arm 6410 (outer sleeve 6410), the first arm and the second arm configured to collectively engage a portion of the peripheral intravenous line 6300.
Regarding claim 11, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the support member 14 is configured to provide lateral support 40, 44 & 46 to limit rotation of the introducer with respect to the target surface.
Regarding claim 12, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the support member 14 includes a plurality of contact surfaces 44 & 46, where each contact surface of the plurality is spaced apart from the others, see Fig. 5-6.
Regarding claim 13, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the support member includes a first portion defining an opening 40 therein extending along an axis and configured to receive a portion of the lock 28 (or lock 6411/6131 in Devgon) therein, and wherein the plurality of contact surfaces 44 & 46 are radially spaced from each other about the axis.
Regarding claim 14, Devgon discloses an apparatus comprising:
a catheter 6200 having a proximal end portion 6220, a distal end portion 6230, and a lumen extending through the proximal end portion and the distal end portion;
an introducer 6100 having a proximal end portion 6120 and a distal end portion 6130, the introducer defining an inner volume configured to movably receive the catheter 6200, see Fig. 11;
an actuator 6500 movably coupled to the introducer 6100 and configured to move relative to the introducer to move the catheter between a first position (in Fig. 9), in which the catheter is disposed within the introducer, and a second position, (in Fig. 12) in which the distal end portion of the catheter 6200, is disposed beyond the distal end portion of the introducer;
a lock 6400 (6410 and/or 6131) attached to the distal end portion 6120 of the introducer 6100, the lock configured to couple to an indwelling peripheral intravenous line 6300, the lock defining a lumen (an interior space of a nose/proboscis of the lock 6410/6411) configured to movably receive the catheter 6200, see Figs. 12-14).
Devgon does not disclose that a support member coupled to the lock, the support member configured to dispose the fluid transfer device at a predetermined angle relative to a target surface, wherein the support member comprises an annular opening encircling at least a portion of the lock.
Godfrey discloses a securement device 14 comprising: a support member 14 coupled to a lock member 28; wherein the support member 14 configured to dispose a fluid transfer device 18 at a predetermined angle, i.e. inclined angle A relative to a target surface P, see Fig. 6; wherein the support member comprises an annular opening 48 (or/and 40) encircling at least a portion (at least ½ bottom portion) of the lock member 28.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Devgon with including a support member being coupled to a lock member, as taught by Godfrey, in order to support catheter and other vascular access device.
Regarding claim 15, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the predetermined angle is substantially equal to an angle of insertion of the peripheral intravenous line, see Fig. 6.
Regarding claim 16, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the lock 28/32 includes a proboscis 27, and wherein the first portion of the support member 14 receives at least a portion of the proboscis therein, see Fig. 5. Therefore, Devgon in view of Godfrey discloses that wherein the first portion 40 of the support member 14 receives at least a portion of the proboscis, i.e., nose of the lock 6411.
Regarding claim 17, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that a hub of the intravenous line 26 being inserted into the proboscis 27. Therefore, Godfrey discloses that wherein at least a portion 27 of the lock 28 is friction fit within the support member. In this case, a person skilled in the art would recognize that the hub of the intervenors line 6300 being inserted into the proboscis/nose of the lock 6400 and that considered as rearrangement parts. Thus, Devgon in view of Godfrey discloses that at least a proboscis portion (nose portion) of the lock 6411/6131 is friction fit within the support member 14 (as modified by Godfrey).
Regarding claim 18, Devgon in view of Godfrey discloses all the claimed subject matter as required. Devgon discloses that wherein the lock includes a first arm (a nose located inside the lock 6411) and a second arm 6410 (outer sleeve 6410), the first arm and the second arm configured to collectively engage a portion of the peripheral intravenous line 6300.
Regarding claim 19, Devgon in view of Godfrey discloses all the claimed subject matter as required. Godfrey discloses that wherein the support member 14 is configured to provide lateral support 40, 44 & 46 to limit rotation of the introducer with respect to the target surface.
Claims 10 & 18 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 2012/0277627) in view of Godfrey (US 2010/0100049) and further in view of Andino et al. (US 2012/0265147).
Regarding claims 10 & 18, in case Applicant disagrees with Examiner with respect to the rejection in claims 10 & 18 above. This claims 10 & 18 are alternatively being rejected as following.
Devgon in view of Godfrey discloses all the claimed subject matter as required. Assuming that the Devgon in view of Godfrey does not disclose that the lock includes a first arm and second arm; wherein the first arm and the second arm configured to collectively engage a portion of the peripheral intravenous line.
Andino discloses a fluid transfer device comprising: a support member 120; a lock 115 includes a first arm 128 and second arm 128, see Fig. 1; wherein the first arm 128 and the second arm 128 configured to collectively engage a portion of a peripheral intravenous line 200, in Fig. 9.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the lock member of Devgon (or Devgon in view of Godfrey) with including first and second arms being engaged to a portion of the intravenous line, as taught by Andino, in order to allow the lock member being engaged to the peripheral intravenous line in different sizes.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 2012/0277627) in view of Andino et al. (US 2012/0265147).
Regarding claim 20, Devgon discloses an apparatus comprising:
a catheter 6200 having a proximal end portion 6220, a distal end portion 6230, and a lumen extending through the proximal end portion and the distal end portion;
an introducer 6100 having a proximal end portion 6120 and a distal end portion 6130, the introducer defining an inner volume configured to movably receive the catheter 6200, see Fig. 11;
an actuator 6500 movably coupled to the introducer 6100 and configured to move relative to the introducer to move the catheter between a first position (in Fig. 9), in which the catheter is disposed within the introducer, and a second position, (in Fig. 12) in which the distal end portion of the catheter 6200, is disposed beyond the distal end portion of the introducer;
a lock 6400 (6410 and/or 6131) attached to the distal end portion 6120 of the introducer 6100, the lock including proboscis/nose; a first arm (outer sleeve of the lock 6411 or 6131); wherein the first arm configured to collective engage a portion of a peripheral intravenous line 6300, see Fig. 11.
Devgon does not disclose that the lock including a second arm; wherein the second arm configured to collectively engage a portion of a peripheral intravenous line. Devgon does not disclose that a support member attached to the lock, the support member configured to dispose the apparatus at a predetermined angle relative to a target surface; the support member defining an annular opening along a central axis thereof, the annular opening receiving at least a portion of the proboscis therein, wherein the first and second arms are substantially perpendicular to the central axis of the annular opening.
Andino discloses a fluid transfer device comprising: a support member 120; a lock 115 includes a first arm 128 and second arm 128, see Fig. 1; wherein the first arm 128 and the second arm 128 configured to collectively engage a portion of a peripheral intravenous line 200, in Fig. 9; a support member 105 configured to dispose an apparatus 200 at a predetermined angle relative to a target surface (Note: the support member 105 (105 alone or 105 & 110) and the apparatus 200 is located in parallel with the target surface, therefore the support member 105 &110 and the apparatus 200 is disposed at predetermined angle, i.e. 0 degrees relative tot the target surface); the support member 105 defining an annular opening (a circular opening is allowing the lock member 115 inserted through, see Fig. 1) along a central axis thereof; the annular opening receiving at least a portion of the proboscis 130 therein (for example: a proximal portion of the proboscis is located inside and inserted through the support member 105); wherein the first and second arms 128 are substantially perpendicular to the central axis (x-axis in the marked-up Fig. 1) of the annular opening. Note: with broadest interpretation, vertical arrow Y (in the marked-up Fig. 1 below) of the arms 128 are substantially perpendicular to the central axis (x-axis) of the annular opening
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It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the lock member of Devgon (or Devgon in view of Godfrey) with including first and second arms being engaged to a portion of the intravenous line, as taught by Andino, in order to allow the lock member being engaged to the peripheral intravenous line in different sizes.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 2012/0277627) in view of Bierman (US 8,585,655).
Regarding claim 1, Devgon discloses a fluid transfer device 6000, in Figs. 9-14 comprising:
an introducer 6100 having a proximal end portion 6120 and a distal end portion 6130, the introducer 6100 defining an inner volume configured to movably receive a catheter 6200, see Fig. 11;
a lock 6131/6411coupled to the distal end portion 6130 and configured to be coupled to an indwelling peripheral intravenous line 6300.
Devgon does not disclose that a support member coupled to the lock, the support member configured to dispose the fluid transfer device at a predetermined angle relative to a target surface; wherein the support member comprises an annular opening encircling at least a portion of the lock.
Bierman discloses a securement device 30 comprising: a support member 30 coupled to a lock member 22; wherein the support member 30 configured to dispose a fluid transfer device (being connected at 24 & 38 of the lock member 2, at a predetermined angle, i.e. inclined angle relative to a target surface, see Figs. 13-14; wherein the support member 30 comprises an annular opening 52/110 encircling at least a portion (1/2 bottom portion) of the lock member 22, see Fig. 14.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Devgon with including a support member being coupled to a lock member, as taught by Bierman, in order to support catheter and other vascular access device.
Regarding claims 2-4, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that wherein the predetermined angle (e.g., about 25-30°, see marked-up figure below) is substantially equal to an angle of insertion of the peripheral intravenous line.
In addition, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to obtain the predetermined angle about 25°, since it has been held that discovering an optimum value (in different direction or different angles of insertion into a patient) of a result effective variable involves only routine skill in the art.
Note: a person skilled in the art would recognize that either the lock 6410 or lock 6131 can be located in the channel 52 in the retainer 30 of Bierman.
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Regarding claim 5, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that wherein the support member 30 includes a first portion 52 configured to receive a portion of the lock 22 in Bierman (which is similar to the lock 6131/6411 in Devgon) therein and a second portion 54 & 28 configured to contact the target surface.
Regarding claim 6, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that wherein the first portion 52 of the support member includes an annular opening 52 extending along an axis (longitudinal axis of the retainer 30), and wherein at least a portion 33 of the second portion 78 (in vertical axis, Fig. 3) is substantially perpendicular to the longitudinal axis.
Regarding claim 7, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that the lock 22 includes a proboscis/nose 38, and wherein the first portion of the support member 30receives at least a portion (proximal portion) of the proboscis 28 therein, see Figs. 13-14. Therefore, Devgon in view of Bierman discloses that wherein the first portion 52 of the support member 30 (in Bierman) receives an outer portion of the sleeve 6410 of the lock 6411 and therefore, the first portion 52 in Bierman also receives at least a portion of the proboscis/nose of the lock 6411 (that located inside the sleeve 6410 of the lock 6411).
Regarding claim 8, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that wherein the support member 30 is releasably attachable to the lock 22 (or the lock 6411/6131 in Devgon).
Regarding claim 9, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that at least a portion of the lock 22 is friction fit within the support member 30, see Figs. 13-14. Therefore, a person skilled in the art would recognize that the lock 6410 or 6131 can be located in the channel 52 and is friction fit within the support member 30 (as modified by Bierman).
Regarding claim 10, Devgon in view of Bierman discloses all the claimed subject matter as required. Devgon discloses that wherein the lock 6410 includes a first arm (a nose located inside the lock 6411) and a second arm 6410 (outer sleeve 6410), the first arm and the second arm configured to collectively engage a portion of the peripheral intravenous line 6300.
Regarding claim 11, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that the support member 30 is configured to provide lateral support to limit rotation of the intruder with respect to the target surface.
Regarding claim 12, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that wherein the support member 30 includes a plurality of contact surfaces 90a-d, 56, 64 & front & back opening (in C-shaped of the retainer); where each contact surface of the plurality is spaced apart from the others, see Figs. 3-4.
Regarding claim 13, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that wherein the support member includes a first portion defining an opening 52 therein extending along an axis and configured to receive a portion of the lock 22 (or lock 6411/6131 in Devgon) therein, and wherein the plurality of contact surfaces 90a-d, 56 & 64 (at C-shaped opening on a right and left side of the retainer 30) & front & back opening (in C-shaped of the retainer) are radially spaced from each other about the axis.
Regarding claim 14, Devgon discloses an apparatus comprising:
a catheter 6200 having a proximal end portion 6220, a distal end portion 6230, and a lumen extending through the proximal end portion and the distal end portion;
an introducer 6100 having a proximal end portion 6120 and a distal end portion 6130, the introducer defining an inner volume configured to movably receive the catheter 6200, see Fig. 11;
an actuator 6500 movably coupled to the introducer 6100 and configured to move relative to the introducer to move the catheter between a first position (in Fig. 9), in which the catheter is disposed within the introducer, and a second position, (in Fig. 12) in which the distal end portion of the catheter 6200, is disposed beyond the distal end portion of the introducer;
a lock 6400 (6410 and/or 6131) attached to the distal end portion 6120 of the introducer 6100, the lock configured to couple to an indwelling peripheral intravenous line 6300, the lock defining a lumen (an interior space of a nose/proboscis of the lock 6410/6411) configured to movably receive the catheter 6200, see Figs. 12-14).
Devgon does not disclose that a support member coupled to the lock, the support member configured to dispose the fluid transfer device at a predetermined angle relative to a target surface; wherein the support member comprises an annular opening encircling at least a portion of the lock.
Bierman discloses a securement device 30 comprising: a support member 30 coupled to a lock member 22; wherein the support member 30 configured to dispose a fluid transfer device (being connected at 24 & 38 of the lock member 2, at a predetermined angle, i.e. inclined angle relative to a target surface, see Figs. 13-14; wherein the support member 30 comprises an annular opening 52/110 encicling at least a portion (1/2 bottom portion) of the lock member 22, see Fig. 14.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Devgon with including a support member being coupled to a lock member, as taught by Bierman, in order to support catheter and other vascular access device.
Regarding claim 15, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that wherein the predetermined angle (e.g., about 25-30°, see marked-up figure below) is substantially equal to an angle of insertion of the peripheral intravenous line.
Regarding claim 16, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that the lock 22 includes a proboscis/nose 38, and wherein the first portion of the support member 30receives at least a portion (proximal portion) of the proboscis 28 therein, see Figs. 13-14. Therefore, Devgon in view of Bierman discloses that wherein the first portion 52 of the support member 30 (in Bierman) receives an outer portion of the sleeve 6410 of the lock 6411 and therefore, the first portion 52 in Bierman also receives at least a portion of the proboscis/nose of the lock 6411 (that located inside the sleeve 6410 of the lock 6411).
Regarding claim 17, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that at least a portion of the lock 22 is friction fit within the support member 30, see Figs. 13-14. Therefore, a person skilled in the art would recognize that the lock 6410 or 6131 can be located in the channel 52 and is friction fit within the support member 30 (as modified by Bierman).
Regarding claim 18, Devgon in view of Bierman discloses all the claimed subject matter as required. Devgon discloses that wherein the lock 6410 includes a first arm (a nose located inside the lock 6411) and a second arm 6410 (outer sleeve 6410), the first arm and the second arm configured to collectively engage a portion of the peripheral intravenous line 6300.
Regarding claim 19, Devgon in view of Bierman discloses all the claimed subject matter as required. Bierman discloses that the support member 30 is configured to provide lateral support to limit rotation of the intruder with respect to the target surface.
Claims 10 & 18 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 2012/0277627) in view of Bierman (US 8,585,655) and further in view of Andino et al. (US 2012/0265147).
Regarding claims 10 & 18, in case Applicant disagrees with Examiner with respect to the rejection in claims 10 & 18 above. This claims 10 & 18 are alternatively being rejected as following.
Devgon in view of Bierman discloses all the claimed subject matter as required. Assuming that the Devgon in view of Bierman does not disclose that the lock includes a first arm and second arm; wherein the first arm and the second arm configured to collectively engage a portion of the peripheral intravenous line.
Andino discloses a fluid transfer device comprising: a support member 120; a lock 115 includes a first arm 128 and second arm 128, see Fig. 1; wherein the first arm 128 and the second arm 128 configured to collectively engage a portion of a peripheral intravenous line 200, in Fig. 9.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the lock member of Devgon (or Devgon in view of Bierman) with including first and second arms being engaged to a portion of the intravenous line, as taught by Andino, in order to allow the lock member being engaged to the peripheral intravenous line in different sizes.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 2012/0277627) in view of Demier, Sr. (US 3,588,149) and Bierman (US 8,585,655).
Regarding claim 20, Devgon discloses an apparatus comprising:
a catheter 6200 having a proximal end portion 6220, a distal end portion 6230, and a lumen extending through the proximal end portion and the distal end portion;
an introducer 6100 having a proximal end portion 6120 and a distal end portion 6130, the introducer defining an inner volume configured to movably receive the catheter 6200, see Fig. 11;
an actuator 6500 movably coupled to the introducer 6100 and configured to move relative to the introducer to move the catheter between a first position (in Fig. 9), in which the catheter is disposed within the introducer, and a second position, (in Fig. 12) in which the distal end portion of the catheter 6200, is disposed beyond the distal end portion of the introducer;
a lock 6400 (6410 and/or 6131) attached to the distal end portion 6120 of the introducer 6100, the lock including proboscis/nose; a first arm (outer sleeve of the lock 6411); wherein the first arm configured to collective engage a portion of a peripheral intravenous line 6300, see Fig. 11
Devgon does not disclose the limitations that: the lock including a second arm; wherein the second arm configured to collectively engage a portion of a peripheral intravenous line; a support member attached to the lock, the support member configured to dispose the apparatus at a predetermined angle relative to a target surface; the support member defining an annular opening along a central axis thereof, the annular opening receiving at least a portion of the proboscis therein, wherein the first and second arms are substantially perpendicular to the central axis of the annular opening.
Demier discloses a fluid transfer device in Figs. 1-4 comprising: a lock 1 includes a first arm 9 and second arm 9 (opposite side of the first arm); wherein the first arm 9 and the second arm 9 configured to collectively engage a hub portion 2 of a peripheral intravenous line 5, also see lock 31 in Fig. 11 can be modified in Devgon.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the lock member of Devgon with including first and second arms being engaged to a hub portion of the intravenous line, as taught by Demier, in order to allow to engage and release the lock member and the hub portion of the intravenous line quickly, and the lock member being engaged to the peripheral intravenous line in different sizes of the hub portion.
Note: the lock member 6410 or 6131 in Devgon is replaced with the lock member 1 (or 31 in Fig. 11), as modified by Demier.
Bierman discloses a securement device 30 comprising: a support member 30 coupled to a lock member 22; wherein the support member 30 configured to dispose a fluid transfer device (being connected at 24 & 38 of the lock member 2, at a predetermined angle, i.e. inclined angle relative to a target surface, see Figs. 13-14; wherein the support member defining an annular opening 52, 88 & 110 along a central axis thereof, see Fig. 3.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Devgon with including a support member being coupled to a lock member, as taught by Bierman, in order to support catheter and other vascular access device.
Thus, Devgon in view of Demier and Bierman discloses that the support member 30 (in Bierman) defining an annular opening 52 along an axis, the annular opening 52 receiving at least a portion of the proboscis/nose (in Devgon) therein (Note: the proboscis/nose is located inside the first and second arms, as shown in Demier), wherein the first and second arms (latching members 10 of the arms 9 in Demier) are substantially perpendicular to the axis (similar to the longitudinal axis with the lock 80a) .
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Response to Arguments
Applicant's arguments filed 10/17/25 have been fully considered but they are not persuasive.
1) Applicant argues that neither Devgon in view of Godfrey nor Devgon in view of Bierman teach of suggest the limitation “the support member comprises an annular opening encircling at least a portion of the lock”
In response, the limitation requires that “an annular opening encircling at least a portion of the lock”. It is noted that the claim does not requires the annular opening encircling an entire of the lock. In this case, Godfrey discloses an annular opening 48 (or/and 40) encircling at least one-half bottom portion of the lock 18/28, see Figs. 5-6. Similarly, Bierman discloses an annular opening 52/110 of the support member 30 is encircling at least a portion (one-half bottom portion) of the lock member 22, see Figs. 13-14.
2) Applicant argues that the C-shaped of latching member 128 in Andino can be constructed as being perpendicular to the central axis of the retainer 102.
In response, the claim 20 requires that: the first and second arms are substantially perpendicular to the central axis of the annular opening. The term “substantially” defines that: being largely but not wholly that which is specified. In other words, the term “substantially” is broadest interpreted such as: almost or close to. Therefore, the first and second arms do not need to be positioned in perfectly perpendicular to the central axis of the annular opening. In this case, the C-shaped (in vertical Y-arrow direction) in the first and second arms 128 are almost or closely perpendicular to the central axis of the annular opening, see marked-up figure 1 below.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783