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 and Request for Continued Examination (RCE) filed on 02/18/26 have been entered in the case. Claims 1-20 are pending for examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 6, it is unclear to the Examiner that the limitation “an annular opening” of the support member in claim 6 is whether same or different with the limitation “an annular opening” in the independent claim 1.
Claim 7 is being rejected due to its dependency.
In claim 13, it is unclear to the Examiner that the limitation “an opening” of the support member in claim 6 is whether same or different with the limitation “an annular opening” in the independent claim 1.
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 Greenwell et al. (US 5,074,847).
Regarding claim 1, Devgon discloses a fluid transfer device 6000/7000, in Figs. 9-14 or in Figs. 15-17, comprising:
an introducer 6100/7100 having a proximal end portion 6120/7120 and a distal end portion 6130/7130, the introducer 6100/7100 defining an inner volume configured to movably receive a catheter 6200/7200, see Figs. 11-12 or Figs. 15-16;
a lock 6131/6411/7130 coupled to the distal end portion 6130/7130 and configured to be coupled to an indwelling peripheral intravenous line 6300/7300.
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 fully encircling at least a portion of the lock.
Greenwell discloses a fluid transfer device 17 comprising: a lock 12; a support member 20 coupled to the lock 12; the support member 20 configured to dispose the fluid transfer device 17 at a predetermined/inclined angle relative to a target surface 18, see Fig. 6; wherein the support member 20 comprises an annular opening 28 fully encircling at least a portion of the lock 12.
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; wherein an annular opening of the support member fully encircling at least a portion of the lock, as taught by Greenwell, in order to support catheter and other vascular access device in a predetermined angle, i.e., an inclined angle.
Note: as discussed in the above, Devgon in view of Greenwell discloses the lock and the support member; wherein the lock 6411 or the lock 6131 (in Fig. 11 of Devgon) or the lock 7130 (Figs. 15-16) can be rested within the annular opening 28 of Greenwell.
Regarding claims 2 & 15, Devgon in view of Greenwell discloses all the claimed subject matter as required. Greenwell discloses that wherein the predetermined angle is substantially equal to an angle of insertion of the peripheral intravenous line, see Fig. 6.
Regarding claims 3-4, Devgon in view of Greenwell discloses all the claimed subject matter as required. Greenwell discloses that the predetermined angle is between 0° and 30° or approximately 25° (e.g. in this case, the predetermined angle is about 25°, see marked-up figure below).
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Regarding claim 5, Devgon in view of Greenwell discloses all the claimed subject matter as required. Greenwell discloses that the support member includes a first portion (at proximal portion) configured to receive a portion of the lock 12 therein (at the opening 28) and a second portion 42/46 configured to contact the target surface 18, see Fig. 6.
Regarding claim 6, Devgon in view of Greenwell discloses all the claimed subject matter as required. Greenwell discloses that the support member includes the annular opening 28 extending along an axis (along a line 24s in Fig. 1), and wherein at least a portion of the second portion 46 is substantially perpendicular to the axis, see Fig. 1. Note: the lines 24s & P are formed an angle α is about 1-35 degrees, col. 6, lines 12-14. For example: if the angleα is about 1-2 degrees or less than 10 degrees, the second portion 46 is substantially perpendicular to the axis (the line 24s).
Regarding claims 7 & 16-17, Devgon in view of Greenwell discloses all the claimed subject matter as required. As discussed in the above, Devgon in view of Greenwell discloses the lock and the support member; wherein the lock 6411 or the lock 6131 (in Fig. 11 of Devgon) or the lock 7130 (Figs. 15-16) can be rested within the annular opening 28 of Greenwell.
Deygon discloses the lock 6131/6411 (Fig. 11) or 7131 (Fig. 15) includes a proboscis, i.e., a nose. In other words, the proboscis is located within the lock. Therefore, the first portion 24s (in Fig. 1, includes the annular opening 28) of the support member 20 receives the lock (and also receives) at least a portion of the proboscis therein.
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Regarding claim 8, Devgon in view of Greenwell discloses all the claimed subject matter as required; wherein the support member 20 is releasably attachable to the lock 12, as suggested by Greenwell, and therefore, the support member 20 is releasably attachable to the lock 6131/6411/7131 in Devgon.
Regarding claim 9, Devgon in view of Greenwell discloses all the claimed subject matter as required; wherein at least portion (outer surface) of the lock 12 is friction fit within the support member (at the annular opening 28). Therefore, at least portion (outer surface of the lock 6131/6411/7131) is friction fit within the support member.
Regarding claims 10 & 18, Devgon in view of Greenwell discloses all the claimed subject matter as required. As best as understood, the lock 6131/6411/7131 includes a first arm (outer sleeve); and a second arm (inner protrusion/nose); wherein the first arm and second arm configured to collectively engage a portion, i.e., hub or handle portion of the peripheral intravenous line 6300/7300, see Figs. 11-12, 16-17.
Regarding claims 11 & 19, Devgon in view of Greenwell discloses all the claimed subject matter as required. Greenwell (or Devgon in view of Greenwell) discloses that the support member 20 is configured to provide lateral support (a combination of the annular opening 28 and the wall 22 or 24s, Figs. 1-2) to limit rotation of the introducer (by friction fit in between the introducer and the annular opening) with respect to the target surface.
Regarding claim 12, Devgon in view of Greenwell discloses all the claimed subject matter as required. Greenwell (or Devgon in view of Greenwell) discloses that the support member 20 includes a plurality of contact surfaces 42, 46; where each contact surface of the plurality is spaced apart from the others.
Regarding claim 13, Devgon in view of Greenwell discloses all the claimed subject matter as required. Greenwell (or Devgon in view of Greenwell) discloses that the support member 20 includes a first portion defining the annular opening 28 therein extending along an axis (for example: along axis of longitudinal of the lock 12 or along an axis of the wall 24s) and configured to receive a portion of the lock therein, and wherein the plurality of the contact surfaces 42, 46 are radially spaced from each other about the axis.
Regarding claim 14, Devgon discloses an apparatus in Figs. 9-14 or in Figs. 15-17,comprising:
a catheter 6200/7200 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 6100/7100 having a proximal end portion 6120/7120 and a distal end portion 6130/7130, the introducer 6100/7100 defining an inner volume configured to movably receive the catheter 6200/7200, see Figs. 11-12 or Figs. 15-16;
an actuator 6500/7500 movably coupled to the introducer 6100/7100 and configured to move relative to the introducer to move the catheter between a first position (in Fig. 9, or Fig. 15), in which the catheter is disposed within the introducer, and a second position, (in Fig. 12 or Figs. 16-17) in which the distal end portion of the catheter 6200/7200, is disposed beyond the distal end portion of the introducer;
a lock 6131/6411/7130 attached to the distal end portion 6130/7130 of the introducer 6100/7100, 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 6410/6411/7130) configured to movably receive the catheter 6200, see Figs. 12-14-17).
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 fully encircling at least a portion of the lock.
Greenwell discloses a fluid transfer device 17 comprising: a lock 12; a support member 20 coupled to the lock 12; the support member 20 configured to dispose the fluid transfer device 17 at a predetermined/inclined angle relative to a target surface 18, see Fig. 6; wherein the support member 20 comprises an annular opening 28 fully encircling at least a portion of the lock 12.
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; wherein an annular opening of the support member fully encircling at least a portion of the lock, as taught by Greenwell, in order to support catheter and other vascular access device in a predetermined angle, i.e., an inclined angle.
Note: as discussed in the above, Devgon in view of Greenwell discloses the lock and the support member; wherein the lock 6411 or the lock 6131 (in Fig. 11 of Devgon) or the lock 7130 (Figs. 15-16) can be rested within the annular opening 28 of Greenwell.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 2012/0277627) in view of Voyten (US 6,213,978).
Regarding claim 20, Devgon discloses an apparatus in Figs. 15-22 comprising:
a catheter 6200/7200 having a proximal end portion 6220/7220, a distal end portion 6230/7230, and a lumen extending through the proximal end portion and the distal end portion;
an introducer 6100/7100 having a proximal end portion 6120/7120 and a distal end portion 6130/7130, the introducer 6100/7100 defining an inner volume configured to movably receive the catheter 6200/7200, see Figs. 11-12 & 15-16;
an actuator 6500/7500 movably coupled to the introducer 6100/7100 and configured to move relative to the introducer to move the catheter between a first position (in Fig. 9 or Fig. 15), in which the catheter is disposed within the introducer 6100/7100, and a second position, (in Fig. 12 or Figs. 16-17) in which the distal end portion of the catheter 6200/7200, is disposed beyond the distal end portion of the introducer;
a lock 6131/6411/7130 attached to the distal end portion 6120/7120 of the introducer 6100/7100, 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 6300/7300, see Figs. 11 & 19.
a support member 6400/7400 configured to dispose the apparatus at a predetermined angle (as best as understood, any angle, even 0 degree, is considered a predetermined angle) relative to a target surface, the support member 6400/7400 defining an annular opening 7430 along a central axis therefor, the annular opening 6430/7430 receiving at least a portion of the proboscis/nose therein.
Devgon does not disclose that the lock including a second arm; wherein each of the first and second arms having a tab configured to collectively engage a portion of a peripheral intravenous line; wherein each tab of the first and second arms project substantially perpendicular toward the central axis of the annular opening.
Voyten discloses a fluid transfer device 10, in Figs. 1-2 comprising: an introducer 50; a lock 40 attached to a distal end portion of the introducer50; the lock 40 including a proboscis 46; a first arm 49, a second arm 49 (opposite to the first arm 49), the first and second arms each having a tab (inwardly projection/hook located at distal end of the arms 49/49) configured o collectively engage a portion of a peripheral intravenous line 20/22, see Fig. 2.
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 device of Devgon with including a lock including a proboscis, a first arm, a second arm, wherein each of the arms having a tab being engaged to a portion of a peripheral intravenous line, as taught by Voyten, for the purposes of allowing the arm of the lock being engaged the with different sizes of a hub/handle of the peripheral intravenous line and preventing accidental disconnection of the peripheral intravenous line.
Thus, Devgon in view of Voyten discloses that each tab of the first and second arms (as modified by Voyten) project substantially perpendicular toward the central axis of the annular opening 7430.
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Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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.
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.
Conclusion
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 on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
