DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/23/26 has been entered.
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 13-14 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.
Regarding claim 13:
The claim limitation “a pair of catheter advancement tabs extending from the catheter adapter” in lines 1 and 2 is unclear. Claim 1 (on which this claim depends) establishes that the catheter adapter includes a stabilization platform and the specification further indicates that these are stabilizing wings/tabs (see ¶0048) however claim 13 indicates that a pair of tabs extends from the catheter adapter in addition to the stabilizing platform. Its unclear if claim 13 is requiring two different tabs or if these overlap or if the catheter advancement tabs refer to some other structure not part of the catheter adapter. For the sake of examination, the office has assumed that the stabilization platform includes the catheter advancement tabs however the applicant should amend the claims to clarify.
Claim 14 is rejected due to its dependence on claim 13.
Regarding claim 14:
The claim limitation “the catheter advancement tabs are detachable from the catheter adapter” in lines 1 and 2 is unclear. As indicated in the rejection of claim 13 above these tabs extend from the catheter adapter which would indicate they are connected to the catheter adapter. Further, there is no embodiment where the tabs connected to the catheter adapter are detachable from the catheter adapter however the tabs 20a/20b are detachable from the catheter insertion device. For the sake of examination, the office has interpreted this limitation to refer to the tabs 20a/20b which are not detachable from the catheter adapter but are detachable from the catheter insertion device. However the applicant should amend the claims to clarify.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 11, 12-16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190209812 A1 to Burkholz et al. (Burkholz).
Burkholz discloses:
Regarding claim 1:
An integrated midline catheter system (figures 7a - 9) comprising:
a catheter adapter (12) having a catheter (14) extending therefrom, a stabilization platform (46/60), a proximal connector portion (74) fluidly coupled to the catheter (14), and a side branch (38) fluidly coupled to the catheter (14);
a near patient access port (44) coupled to the side branch (38) of the catheter adapter (12), wherein the near patient access port (44) comprises a connector portion (see connectors A or B in figure 1 below) couplable to a peripheral probe device (interpreted as intended use which the ports A and B in figure 1 would be capable of connecting to); and
a catheter insertion device (see 48/22/18), wherein when the catheter insertion device (48/22/18) is coupled to the catheter adapter (12) (coupled to the catheter adapter 12 via 16), the catheter insertion device (48/22/18) enables distal movement of the catheter adapter (12) and catheter (14) with respect to the catheter insertion device (48/22/18) (the catheter insertion device see 48/22/18 moves relative to the catheter adapter and catheter (or the catheter adapter and catheter moves relative to the catheter insertion device) when removing the needle 18) so as to position the catheter (14) within a patient's vasculature (this movement leaves the catheter 14 positioned within the vein of the patient; ¶0095).
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Figure 1 - figure 3a of Burkholz, annotated by the examiner
Regarding claim 2:
The system of claim 1, wherein the near patient access port (44) further comprises a secondary port (A in figure 1 above instead of connector portion B), and wherein the secondary port (A in figure 1 above) is coupled to an integrated extension set (34).
Regarding claim 3:
The system of claim 2, further comprising a proximal access port (see the port C in figure 1 above) coupled to a proximal end portion (coupled to 34 at the proximal end of 34) of the integrated extension set (34).
Regarding claim 6:
The system of claim 1, wherein the connector portion (see connectors A or B in figure 1 above) of the near patient access port (44) is a needle-free connector (as shown in figure 1 above).
Regarding claim 11:
The system of claim 1, wherein the stabilization platform comprises a pair of stabilizing wings (46/60).
Regarding claim 12:
The system of claim 11, wherein each of the stabilizing wings (46/60) comprises a gripping surface to provide a grip (as shown in figure 3B with fingers 58) for the distal movement of the catheter adapter and catheter along the catheter insertion device (as shown in figure 9 48/22/18 are moved distally away from 12).
Regarding claim 13 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
The system of claim 1, further comprising a pair of catheter advancement tabs (46/60) extending from the catheter adapter (12) and configured to provide to provide a grip for the distal movement (as shown in figure 9 48/22/18 are moved distally away from 12) of the catheter adapter (12) and catheter (14) along the catheter insertion device (48/22/18).
Regarding claim 14 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
The system of claim 13, wherein the catheter advancement tabs (46/60) are detachable from (as indicated above the office has interpreted this limitation to indicate the catheter advancement tabs are detachable form the catheter insertion device) the catheter adapter (12).
Regarding claim 15:
The system of claim 1, wherein the catheter insertion device (48/22/18) further comprises a housing (24/22), an introducer needle (18) extending distally from the housing (as shown in figure 7b), and an actuator tab (48) slidable along the housing to selectively advance a guidewire (20) through the introducer needle (as shown in figure 6b), wherein the catheter (14) is configured to selectively advance over the introducer needle and the guidewire (as shown in figure 6b).
Regarding claim 16:
The system of claim 1, wherein the catheter adapter (12) is at least partially disposed within (as shown in figure 7b) the catheter insertion device (48/22/18), and wherein the catheter insertion device (48/22/18) is detachable from the catheter adapter (12) after insertion of the catheter within the patient's vasculature (as shown in figure 9).
Regarding claim 19:
The system of claim 1, wherein the near patient access port (44) further comprises a secondary port (A in figure 1 above), and wherein the secondary port (A in figure 1 above) is coupled (as shown in figure 3a) to an integrated extension set (34).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190209812 A1 to Burkholz et al. (Burkholz) as applied to claim 3 above, and further in view of US 20120253295 A1 to Nentwick et al. (Nentwick).
Regarding claim 4:
Burkholz fails to disclose:
The system of claim 3, wherein the proximal access port is color-coded to provide a flow rate indication.
Nentwick teaches:
A catheter system (see figure 5) that includes a catheter (10) with a catheter adapter (90). Further, the reference teaches that replacement tubing (243), replacement clamps (246), and replacement fittings (240) can be color coded to indicate the use of these structures (¶0114). These uses or attributes can include the flow rate of these structures (¶0114).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz to make the proximal access port color coded as taught by Nentwick in order to indicate the flow rate of the port (¶0114) to prevent errors or misuse of the proximal access port.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190209812 A1 to Burkholz et al. (Burkholz) as applied to claim 3 above, and further in view of US 4362156 A to Feller et al. (Feller).
Regarding claim 5:
Burkholz fails to disclose:
The system of claim 3, wherein the proximal access port comprises indicia indicative of at least one of catheter length and catheter gauge.
Feller teaches:
A catheter system (see figure 2) that includes a catheter (22) with a catheter adapter (10). The reference further shows a port (26) with an indicia (74) for indicating the gauge of the catheter (column 6, lines 55-60).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz to include an indicia on the proximal access port to indicate the catheter gauge as taught by Feller to prevent errors in the use of the system.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190209812 A1 to Burkholz et al. (Burkholz) as applied to claim 6 above, and further in view of US 20190321599 A1 to Burkholz et al. (Burkholz ‘599).
Regarding claim 7:
Burkholz fails to disclose:
The system of claim 6, wherein the needle-free connector is a split septum needle-free connector.
Burkholz ‘599 teaches:
A catheter system (see figure 1A) that includes a catheter (20) with a catheter adapter (12). The reference further shows a port (30; near patient access port) with a split septum needle-free connector (¶0040).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz to replace the needle-free connector with a split septum needle-free connector as taught by Burkholz ‘599 . This is a simple substitution of one known element (the needle free connector in Burkholz) for another (split septum needle-free connector as taught by Burkholz) to obtain predictable results (to allow fluid communication between the catheter and any structure attached to the connector).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190209812 A1 to Burkholz et al. (Burkholz) as applied to claim 1 above, and further in view of US 5501674 A to Trombley et al. (Trombley).
Regarding claim 8:
Burkholz fails to disclose:
The system of claim 1, wherein the near patient access port further comprises a high-pressure injection port.
Trombley teaches:
A catheter system (see figure 1) that includes a catheter (42) with a catheter adapter (40). The reference further shows a port (20) that is a high-pressure injection port (column 2, lines 9-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz to make the near patient access port a high pressure injection port as taught by Trombley to allow for medication to be introduced into the catheter (Trombley, column 2, lines 9-14).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190209812 A1 to Burkholz et al. (Burkholz) and US 5501674 A to Trombley et al. (Trombley) as applied to claim 8 above, and further in view of US 20120253295 A1 to Nentwick et al. (Nentwick).
Regarding claim 9:
Burkholz fails to disclose:
The system of claim 8, wherein the high-pressure injection port is color- coded to provide a flow rate indication.
Nentwick teaches:
A catheter system (see figure 5) that includes a catheter (10) with a catheter adapter (90). Further, the reference teaches that replacement tubing (243), replacement clamps (246), and replacement fittings (240) can be color coded to indicate the use of these structures (¶0114). These uses or attributes can include the flow rate of these structures (¶0114).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz to make the high-pressure injection port color coded as taught by Nentwick in order to indicate the flow rate of the port (¶0114) to prevent errors or misuse of the proximal access port.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190209812 A1 to Burkholz et al. (Burkholz) and US 5501674 A to Trombley et al. (Trombley) as applied to claim 8 above, and further in view of US 4362156 A to Feller et al. (Feller).
Regarding claim 10:
Burkholz fails to disclose:
The system of claim 8, wherein the high-pressure injection port includes indicia indicative of at least one of catheter length and catheter gauge.
Feller teaches:
A catheter system (see figure 2) that includes a catheter (22) with a catheter adapter (10). The reference further shows a port (26) with an indicia (74) for indicating the gauge of the catheter (column 6, lines 55-60).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz to include an indicia on the high-pressure injection port to indicate the catheter gauge as taught by Feller to prevent errors in the use of the system.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190209812 A1 to Burkholz et al. (Burkholz) as applied to claim 1 above, and further in view of WO 2009091514 A2 to Keyser et al. (Keyser).
Regarding claim 18:
Burkholz fails to disclose:
The system of claim 1, wherein the catheter is between 8 cm and 10 cm in length.
Keyser teaches:
A catheter system (see figure 48a) that includes a catheter (13) that extends over a needle (12). Further, the reference teaches that catheters can have a typical length of 15 to 1 cm (¶0081).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burkholz to make the catheter length 1-15 cm (overlapping with 8-10cm as required by the claim) as taught by Keyser since catheters have this length to suit their intended function (Keyser, ¶0081).
Response to Arguments
Applicant’s arguments, see remarks, filed 6/23/26, with respect to the rejection(s) of claim(s) 1-16, 18 and 19 under 35 USC 102 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 Burkholz.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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