DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on 11/10/2025. As directed by the amendment: claims 2, 7, 9, 12, and 17 have been amended. Claims 1, 10 and 11 have been cancelled.
Thus, claims 2-9 & 12-23 are pending in this application.
Applicant’s amendments to the drawings and specification have overcome each and every objection previously set forth in the Non-final Office Action mailed on 08/12/2025.
Applicant’s amendments to the claims have overcome each and every 112(b) claim rejection previously set forth in the Non-final Office Action mailed on 08/12/2025.
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.
Claim 22 is 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.
Claim 22 recites the limitation “wherein the actuator in the first position is axially aligned with the actuator in the second position along a common longitudinal axis defined between the distal end and the proximal end of the catheter anchor device”. This limitation is unclear as the claim only states an actuator that shifts the anchors from a first position to a second, thus it is indefinite for the actuator in the first position to axially align with the actuator in the second position along a common longitudinal axis defined between the distal end and the proximal end of the catheter anchor device.
Clarification is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 7-9 and 12-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Glenn (US 20070232997 A1) in view of Kerr (US 20060129134 A1).
Regarding claim 2, Glenn discloses a method (figs 1-8, claim 1) comprising: advancing flexible anchors (60) of a catheter anchor device (10) through a percutaneous opening in a skin layer (see figs 1 and 2, para 0045) so that the flexible anchors (60) is disposed in a subcutaneous region along an underside of the skin layer (see fig 2 and para 0045); moving a catheter (20) through the percutaneous opening in the skin layer toward a targeted body site (see figs 1-2); and adjusting an actuator (70/50) of the catheter anchor device (10) between a first position in which the flexible anchors are deployed (see fig 1, wings 60 are spread out) and a second position in which the flexible anchors are undeployed (see fig 2, wings 60 collapsed together).
Glenn fails to teach said method discloses a subcutaneous cuff device that is disposed in a subcutaneous region along an underside of the skin layer and comprising a biocompatible material configured to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer and wherein the subcutaneous cuff device is positioned closer to a distal end of the catheter anchor device than to a proximal end of the catheter anchor device and distal of the flexible anchors, wherein said catheter is moved relative to the subcutaneous cuff device disposed in the subcutaneous region along the underside of the skin layer, wherein the flexible anchors located closer to the actuator than to the subcutaneous cuff device when deployed, and wherein a distance between the actuator and the subcutaneous cuff device along a longitudinal axis of the catheter anchor device is greater in the first position than in the second position.
However, Kerr discloses a method of performing dialysis with a catheter system (see fig 1A, system 32) comprising a catheter anchor device and (10) and a subcutaneous cuff device (26) disposed in a subcutaneous region along an underside of the skin layer (para 0056) and comprising a biocompatible material (para 0018) that configured to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer (para 0018 and 0056) wherein the subcutaneous cuff device (20) is positioned closer to a distal end (24) of the catheter anchor device (10) than to a proximal end (22) of the catheter anchor device (see fig 1A, cuff 20 is closer to distal end 24 of tube 10) and a distal tip (tip of distal end 16) of a catheter (12) is moved relative to the subcutaneous cuff device (26) disposed in the subcutaneous region along the underside of the skin layer (see fig 1A, para 0056, distal end 16 will be positioned at a selected location in a blood vessel of the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Glenn and incorporate the teachings of Kerr to have a subcutaneous cuff device disposed in a subcutaneous region along an underside of the skin layer and comprising a biocompatible material that configured to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer wherein the subcutaneous cuff device is positioned closer to a distal end of the catheter anchor device than to the proximal end of the catheter anchor device and a distal tip of saif catheter moved relative to the subcutaneous cuff device disposed in the subcutaneous region along the underside of the skin layer. This would provide the benefit of having a subcutaneous cuff device positioned closer to the distal end of said catheter anchor device to receive tissue ingrowth and help in fixing said catheter at selected location relative to a subcutaneous tunnel (see para 0018). Furthermore, having said subcutaneous cuff device positioned closer to the distal end of said catheter anchor device of Glenn would make said the flexible anchors of Glenn located closer to the actuator than to the subcutaneous cuff device when deployed (see annotated figure below), and a distance between the actuator and the subcutaneous cuff device along a longitudinal axis of the catheter anchor device is greater in the first position (fig 1 of Glenn) than in the second position (see fig 2 of Glenn and annotated figure below).
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Regarding claim 7, Glenn in view of Kerr discloses the method of claim 2,
Glenn further discloses wherein after said moving the catheter (20) toward the targeted body site (see fig 1), the distal end of the catheter anchor device resides external to a venous entry point of a blood vessel that is occupied by the catheter (see figs 1 and 2, distal end of device 10 is external to venous entry point).
Regarding claim 8, Glenn in view of Kerr discloses the method of claim 2,
Glenn further discloses wherein the flexible anchors (60) are adjustable from a non-deployed orientation (fig 2) to a deployed orientation (fig 1) in the subcutaneous region along the underside of the skin layer (see figs 1 and 2, para 0078).
Regarding claim 9, Glenn in view of Kerr discloses the method of claim 2,
Glenn further discloses wherein the catheter anchor device comprises a sleeve body (retainer 10 comprises fixed sleeve 40, see fig 1) having a lumen configured to receive the catheter (20) wherein the subcutaneous cuff device (26) is mounted along an exterior of the sleeve body (cuff 26 in the modified of Glenn would be mounted along an exterior of the sleeve body 40).
Kerr also discloses wherein the catheter anchor device (10) comprises a sleeve body having a lumen configured to receive the catheter (12), and wherein the subcutaneous cuff device (26) is mounted along an exterior of the sleeve body (see fig 1A).
Regarding claim 12, Glenn in view of Kerr discloses the method of claim 2,
Glenn further discloses wherein a distance between the actuator and the flexible anchors when in the deployed configuration (fig 1) is less than a distance between the subcutaneous cuff device and the distal end of the catheter anchor device (see fig 1 of Glenn, in deployed configuration, sleeve 50 is attached to wings 60 meaning the distance is very less if the cuff 26 is placed at the distal of device 10).
Regarding claim 13, Glenn in view of Kerr discloses the limitations of claim 2 but fail to teach wherein the catheter anchor device has a tapered region that tapers towards the distal end.
However, Kerr disclose a method of performing dialysis with a catheter system (see fig 9, system 80) wherein the catheter anchor device has a tapered region that tapers towards the distal end (see fig 9 and para 0064).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the catheter anchor device of Glenn and incorporate the teachings of Kerr to have the catheter anchor device has a tapered region that tapers towards the distal end. This would facilitate insertion of said catheter anchor through the skin and ensure that the distal end of the catheter can be positioned precisely and that the cuff can be disposed at the preferred position for anchoring in the tunnel (see para 0064).
Regarding claim 14, Glenn in view of Kerr discloses the method of claim 13,
Kerr further discloses the subcutaneous cuff device (cuff 90) is located on the tapered region of the catheter anchor device (see figs 9-10, para 0064).
Regarding claim 15, in the modified device of Glenn, Glenn in view of Kerr discloses the method of claim 2, wherein the subcutaneous cuff device is mounted to a catheter engagement body of the catheter anchor device (10) at a position such that the subcutaneous cuff device is configured to reside in the subcutaneous region along the underside of the skin layer while at least a proximal portion of the catheter engagement body resides external to the skin layer (see figs 1 and 2, cuff of Kerr would be positioned at the distal end of retainer 10 and resides in the subcutaneous region along the underside of the skin layer and while a portion of sleeve 50 resides external to the skin layer, para 0075).
Regarding claim 16, Glenn in view of Kerr discloses the method of claim 15,
Glenn further discloses wherein the catheter engagement body comprises a sleeve body (40/50) having a lumen to receive the catheter (see figs 1 and 2).
Regarding claim 17, Glenn in view of Kerr discloses the method of claim 2,
Glenn further discloses wherein the actuator adjusts from the first position (fig 1) to the second position (fig 2) so as to simultaneously deploy the flexible anchors (fig 1) and to shift an interior gripper (interior of retainer 10) of the catheter anchor device to compress an outer surface of the catheter (para 0063).
Regarding claim 18, Glenn in view of Kerr discloses the method of claim 2,
Kerr further discloses the subcutaneous cuff device (cuff 26) inhibits migration of infection when the subcutaneous cuff device is embedded in the subcutaneous region along the underside of the skin layer (para 0056).
Regarding claim 19, Glenn in view of Kerr discloses the method of claim 2,
Kerr further discloses the subcutaneous cuff device is configured to receive the ingrowth of bodily tissue over a period of time so as to inhibit migration of infection from outside the skin and into a blood stream (para 0056).
Regarding claim 20, Glenn in view of Kerr discloses the method of claim 2,
Glenn further discloses wherein the catheter anchor device (10) includes an interior gripper (interior of retainer 10 with teeth 44) that is adjustable to frictionally engage at least a portion of an outer circumferential surface of the catheter (fig 2, para 0061 and 0063).
Regarding claim 21, Glenn in view of Kerr discloses the method of claim 2,
Glenn discloses said method further comprising releasably securing the catheter (20) to the catheter anchor device (10) by shifting the gripper portion (44) to releasably compress against an outer circumferential surface of the catheter after each of the catheter and the anchors (56) is inserted through the percutaneous opening in the skin layer (see fig 2 and para 0061 and 0063).
Regarding claim 22, Glenn discloses method (figs 1-8), comprising: advancing a first flexible anchor and a second flexible anchor (60) of a catheter anchor device (10) through a percutaneous opening in a skin layer so that the first and second flexible anchors of the catheter anchor device are disposed in a subcutaneous region along an underside of the skin layer (see figs 1-2, para 0045); moving a catheter (20) through the percutaneous opening in the skin layer toward a targeted body site (see figs 1-2); and adjusting an actuator (70/50) of the catheter anchor device between a first position and a second position to shift the first and second flexible anchors to a deployed configuration (figs 1-2), wherein the actuator in the first position is axially aligned with the actuator in the second position along a common longitudinal axis defined between the distal end and the proximal end of the catheter anchor device (see figs 1-2).
Glenn fails to teach said method discloses a subcutaneous cuff device that is disposed in a subcutaneous region along an underside of the skin layer and comprising a biocompatible material that is configured to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer and wherein the subcutaneous cuff device is positioned closer to a distal end of the catheter anchor device than to a proximal end of the catheter anchor device and distal of the flexible wings, wherein said catheter is moved relative to the subcutaneous cuff device disposed in the subcutaneous region along the underside of the skin layer, wherein the flexible anchors located closer to the actuator than to the subcutaneous cuff device when deployed, and wherein a distance between the actuator and the subcutaneous cuff device along a longitudinal axis of the catheter anchor device is greater in the first position than in the second position.
However, Kerr discloses a method of performing dialysis with a catheter system (see fig 1A, system 32) comprising a catheter anchor device and (10) and a subcutaneous cuff device (26) disposed in a subcutaneous region along an underside of the skin layer (para 0056) and comprising a biocompatible material (para 0018) that configured to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer (para 0018 and 0056) wherein the subcutaneous cuff device (20) is positioned closer to a distal end (24) of the catheter anchor device (10) than to a proximal end (22) of the catheter anchor device (see fig 1A, cuff 20 is closer to distal end 24 of tube 10) and a distal tip (tip of distal end 16) of a catheter (12) is moved relative to the subcutaneous cuff device (26) disposed in the subcutaneous region along the underside of the skin layer (see fig 1A, para 0056, distal end 16 will be positioned at a selected location in a blood vessel of the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Glenn and incorporate the teachings of Kerr to have a subcutaneous cuff device disposed in a subcutaneous region along an underside of the skin layer and comprising a biocompatible material that configured to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer wherein the subcutaneous cuff device is positioned closer to a distal end of the catheter anchor device than to the proximal end of the catheter anchor device and a distal tip of saif catheter moved relative to the subcutaneous cuff device disposed in the subcutaneous region along the underside of the skin layer. This would provide the benefit of having a subcutaneous cuff device positioned closer to the distal end of said catheter anchor device to receive tissue ingrowth and help in fixing said catheter at selected location relative to a subcutaneous tunnel (see para 0018). Furthermore, having said subcutaneous cuff device positioned closer to the distal end of said catheter anchor device of Glenn would make said the flexible anchors of Glenn located closer to the actuator than to the subcutaneous cuff device when deployed (see annotated figure above), and a distance between the actuator and the subcutaneous cuff device along a longitudinal axis of the catheter anchor device is greater in the first position (fig 1 of Glenn) than in the second position (see fig 2 of Glenn and annotated figure above).
Regarding claim 23, Glenn in view of Kerr discloses the method of claim 2,
Glenn further discloses wherein the actuator in the second position (fig 2) contacts a stopper (45, figs 3-5) of the catheter anchor device (10, sleeve 50 comes in contact with the proximal end of sleeve 40 in second position, see fig 2), the stopper located closer to the actuator than to the subcutaneous cuff device (see fig 4, end 52 of sleeve 50 is closer to proximal end 45 than cuff 26 of Kerr when mounted to distal end of sleeve 40).
Claims 3-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Glenn (US 20070232997 A1) in view of Kerr (US 20060129134 A1) and further in view of Raulerson (US 5599311 A).
Regarding claim 3, Glenn in view of Kerr discloses the limitations of claim 2 but fail to teach said method wherein after said moving the catheter toward the targeted body site, a distal length of the catheter extending distally from a distal end of the catheter anchor device is greater than a maximum length of the catheter anchor device.
However, Raulerson teaches methods for securing a catheter in a subcutaneous location (fig 7) wherein after said moving a catheter (60) toward the targeted body site (see fig 7), a distal length of the catheter extending distally from a distal end of a catheter anchor device (74) is greater than a maximum length of the catheter anchor device (see fig 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Glenn in view of Kerr and incorporate the teachings of Raulerson to have a distal length of the catheter extending distally from a distal end of the catheter anchor device to be greater than a maximum length of the catheter anchor device. This would provide the benefit of having a sufficient length of catheter to be moved through the opening of the skin to the target site and to be able to be adjusted depending on the patient's size or the patient's anatomy (see col 10, lines 42-54).
Regarding claim 4, Glenn in view of Kerr and Raulerson disclose the method of claim 3,
Kerr further discloses a longitudinal distance from the subcutaneous cuff device to the distal catheter tip defines a cuff-to-tip distance (see fig 1A, distance between cuff 26 and catheter tip 16) and wherein said moving causes adjustment of the cuff-to-tip distance while the subcutaneous cuff device is disposed in the subcutaneous region along the underside of the skin layer (see para 0010-11 and 0015).
Regarding claim 5, Glenn in view of Kerr and Raulerson disclose the method of claim 4,
Kerr further discloses wherein the cuff-to-tip distance between the subcutaneous cuff device and the distal tip of the catheter is manually selectable (para 0010-11 and 0015).
Regarding claim 6, Glenn in view of Kerr and Raulerson disclose the method of claim 5,
Kerr further discloses said method comprising releasably securing the catheter to the catheter anchor device after the adjustment of the cuff-to-tip distance (para 0025 and 0058).
Response to Arguments
Applicant's arguments filed on 11/10/2025 have been fully considered but they are not persuasive.
With regard to the arguments that none of the cited documents teach or suggest at least this subject matter, along with the additional features recited in claim 2, "adjusting an actuator of the catheter anchor device relative to the subcutaneous cuff device between a first position in which the flexible anchors are deployed and a second position in which the flexible anchors are undeployed, the flexible anchors located closer to the actuator than to the subcutaneous cuff device when deployed, wherein a distance between the actuator and the subcutaneous cuff device along a longitudinal axis of the catheter anchor device is greater in the first position than in the second position.", examiner respectfully disagrees. Glenn discloses adjusting an actuator (70/50) of the catheter anchor device (10) between a first position in which the flexible anchors are deployed (see fig 1, wings 60 are spread out) and a second position in which the flexible anchors are undeployed (see fig 2, wings 60 collapsed together) but fail to teach the flexible anchors located closer to the actuator than to a subcutaneous cuff device when deployed, wherein a distance between the actuator and the subcutaneous cuff device along a longitudinal axis of the catheter anchor device is greater in the first position than in the second position.
However, Kerr discloses a method of performing dialysis with a catheter system (see fig 1A, system 32) comprising a catheter anchor device and (10) and a subcutaneous cuff device (26) wherein the subcutaneous cuff device (20) is positioned closer to a distal end (24) of the catheter anchor device (10) than to a proximal end (22) of the catheter anchor device (see fig 1A, cuff 20 is closer to distal end 24 of tube 10).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Glenn and incorporate the teachings of Kerr to have a subcutaneous cuff device positioned closer to a distal end of the catheter anchor device than to a proximal end of the catheter anchor device. Having said subcutaneous cuff device positioned closer to the distal end of said catheter anchor device of Glenn would make said the flexible anchors of Glenn located closer to the actuator than to the subcutaneous cuff device when deployed and a distance between the actuator and the subcutaneous cuff device along a longitudinal axis of the catheter anchor device is greater in the first position (fig 1 of Glenn) than in the second position (see fig 2 of Glenn and annotated figure above).
Thus, the rejections of claim 2-9, 13-21 are maintained.
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.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783