DETAILED ACTION
Response to Amendment
Acknowledgements
The claim objections have been resolved by the amendments filed on 6/19/2026.
The 101 rejections has been obviated by the amendments filed on 6/19/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5-7, 10-11, 14-16, and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. (US 2001/0016730; hereafter Martins) in view of .
In regard to claim 1, Martins discloses a fluid system comprising: a port (86) configured to be implanted in a patient (see par. [0009], [0092], [0094]); and a catheter (100) configured to be implanted in the patient and in fluid communication with the port (see Figs. 3-4 and par. [0094]), the catheter comprising a catheter shaft (105) having a first tubing (225; see at least Fig. 22) arranged concentrically around a second tubing (210; see at least Fig. 22) and defining a gap therebetween (there is a gap in the space 135 occupies), and a reinforcement layer (135; see at least par. [0066]) disposed between the first tubing and the second tubing (see at least Figs. 22-23 including 22a and 23a).
In regard to claim 1, Martins discloses that the reinforcement layer (135) is formed in either a braid ("tubular, braided mesh reinforcer") or a coil ("coil spring 140") (see par. [0108]). Martins fails to disclose that the braid or coil comprises multifilament yarn as is recited in claim 1.
In a similar art, Beisel teaches a catheter (see Fig. 8) with an inner tubing (36), and outer tubing (44), and a reinforcement layer (42a, 42b) in the form of a coil comprising Vectran multifilament yarn (see col. 14, lines 29-45).
In view of the teaching of Beisel, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the Vectran multifilament yarn in the Martins device because it amounts to selection of a known material and configuration based on its known suitability for the purpose. There is a reasonable expectation of success in making the modification because the reinforcing means of Beisel is directed to preventing luminal collapse and increasing tensile strength (see the Abstract of Beisel).
In regard to claim 2, Martins discloses wherein the catheter is configured to sample fluid from at least one of a spinal region or a brain region of the patient (see par. [0094]; this limitation is understood by the examiner to be a functional limitation; the Martins system is configured for implantation and delivery/withdrawal of fluid).
In regard to claim 3, Martins discloses further comprising a pump ("hemodialysis machine") configured to at least one of pump a fluid sample to the port via the catheter or pump a therapeutic to the patient from the port via the catheter (see par. [0003], [0006], and [0094]; the hemodialysis machine withdraws blood from the catheter and pumps it back into the patient after treating).
In regard to claim 5, Martins and Beisel both teach wherein the reinforcement layer comprises multifilament yarn is formed in at least one of a braid or a coil (see par. [0108] of Martins and col. 14, lines 29-45 of Beisel).
In regard to claim 6, Beisel discloses that the Vectran multifilament yarn is an aromatic polyester (see col. 12, lines 28-29).
In regard to claim 7, Beisel discloses that the reinforcing member comprises radiopaque filler, comprising at least one barium, tungsten, tantalum, or bismuth (see col. 8, lines 20-50).
In regard to claim 10, Martins discloses wherein each of the first tubing and the second tubing comprises at least one of silicone, polyurethane, polyamide, polyester, fluoropolymers, or copolymers (see par. [0080] and [0083]).
In regard to claim 11, Martins discloses a fluid system comprising: a port (86) configured to be implanted in a patient (see par. [0009], [0092], [0094]); and a catheter (100) configured to be implanted in the patient and in fluid communication with the port (see Figs. 3-4 and par. [0094]), the catheter comprising a catheter shaft (105) having a first tubing (225; see at least Fig. 22) arranged concentrically around a second tubing (210; see at least Fig. 22) to define a gap therebetween (there is a gap in the space 135 occupies); and a reinforcement layer (135; see at least par. [0066]) disposed in the gap between the first tubing and the second tubing (see at least Figs. 22-23 including 22a and 23a), wherein the reinforcement layer (135) is formed in either a braid ("tubular, braided mesh reinforcer") or a coil ("coil spring 140") (see par. [0108]).
Martins fails to expressly disclose that the reinforcement layer comprises radiopaque multifilament.
In a similar art, Beisel teaches a catheter (see Fig. 8) with an inner tubing (36), and outer tubing (44), and a reinforcement layer (42a, 42b) in the form of a coil comprising Vectran multifilament yarn (see col. 14, lines 29-45). Beisel further discloses that the reinforcing member comprises radiopaque filler, comprising at least one barium, tungsten, tantalum, or bismuth (see col. 8, lines 20-50).
In view of the teaching of Beisel, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the Vectran multifilament yarn in the Martins device because it amounts to selection of a known material and configuration based on its known suitability for the purpose. There is a reasonable expectation of success in making the modification because the reinforcing means of Beisel is directed to preventing luminal collapse and increasing tensile strength (see the Abstract of Beisel) and also providing radiopacity to the catheter to help locate the implanted position of the catheter.
In regard to claim 14, Martins discloses further comprising a pump ("hemodialysis machine") configured to at least one of pump a fluid sample to the port via the catheter or pump a therapeutic to the patient from the port via the catheter (see par. [0003], [0006], and [0094]; the hemodialysis machine withdraws blood from the catheter and pumps it back into the patient after treating).
In regard to claim 15, Martins discloses wherein the catheter is configured to sample fluid from at least one of a spinal region or a brain region of the patient (see par. [0094]; this limitation is understood by the examiner to be a functional limitation; the Martins system is configured for implantation and delivery/withdrawal of fluid).
In regard to claim 16, Martins discloses wherein each of the first tubing and the second tubing comprises silicone (see par. [0080] and [0083]).
In regard to claim 21, the combination teaches wherein the multifilament yarn disposed in the gap forms a reinforcement layer of the catheter (the modified 135 is the reinforcing layer).
In regard to claim 22, the combination teaches wherein the multifilament yarn is a radiopaque multifilament yarn (see col. 8, lines 20-50).
In regard to claim 23, the combination teaches wherein the first tubing and the second tubing are configured to prevent exposure of the multifilament yarn to an internal environment of the patient (the modified layer 135 is within the inner and outer tubing).
In regard to claim 24, the combination teaches wherein the multifilament yarn disposed in the gap improves one or more of a durability, a kink-resistance, or a radiopacity of the catheter (the modified 135 is a reinforcing layer).
In regard to claim 25, the combination teaches wherein the reinforcement layer improves one or more of a durability, a kink-resistance, or a radiopacity of the catheter (the modified 135 is a reinforcing layer).
In regard to claim 26, the combination teaches wherein the first tubing and the second tubing are configured to prevent exposure of the radiopaque multifilament to an internal environment of the patient (the modified layer 135 is within the inner and outer tubing).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Martins and Beisel in view of Lyu et al. (US 2012/0289881; hereafter Lyu).
In regard to claim 4, Martins fails to expressly disclose wherein the pump is implanted in the patient.
In a similar hemodialysis system, Lyu discloses an embodiment wherein the dialyzer (25) and blood pump (located within the dialyzer) are implantable within the patient (see par. [0140]-[0141]. Lyu teaches that an implantable hemodialysis system can provide continuous hemofiltration or continuous hemodiafiltration that would enhance patient mobility and reduce complications related to vascular access and extracorporeal blood processing. Furthermore, there is a need for an implantable hemodiafiltration device capable of operating at a pressure similar to that of a patient's blood pressure, and at a rate similar to that of natural kidney function to provide more consistent and beneficial therapy as compared to existing intermittent treatment regimens. Additionally, an implantable device used for dialysis or ultrafiltration is needed that would eliminate the need for visiting a dialysis clinic for treatments, and improve patient compliance with dialysis prescriptions. An implantable hemodiafiltration device used for dialysis or ultrafiltration operable at a patient's average blood pressure would thus permit blood, treatment schedules that are suitable and adaptable to a patient's lifestyle, thereby promoting patient health and enhancing patient quality of life (see at least par. [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Martins with the implantable pump configuration of Lyu in order to provide increased patient mobility, comfort, and quality of life.
Claim(s) 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Martins and Beisel and further in view of McGurk (US 5,676,659).
In regard to claims 8 and 12, Martins discloses that the reinforcing member can be formed of a braid and Beisel teaches the multifilament yarn but neither reference expressly discloses a one-over-one pattern, two-over-two pattern, or three-over-three pattern.
In a similar art, McGurk discloses a catheter (10) with an inner member (30), an outer member (34), and a reinforcing member (32) in the form a braid in one-over-one pattern or a two-over-two pattern. McGurk teaches that such patterns are conventional in the braid reinforcing art (see col. 3, lines 65-68 and col. 7, lines 14-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with patterns of McGurk as such braid patterns are conventional and known in the art to produce predictable results.
Response to Arguments
Applicant's arguments filed 6/19/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Martins fails to disclose a first tubing arranged concentrically around a second tubing and defining a gap therebetween, the examiner respectfully disagrees. Martins discloses an outer tube (225) concentrically arranged around an inner tube (210), wherein reinforcing element (135) creates a gap between the inner and outer tubes in the space taking up by reinforcing element (135). This situation is analogous to the applicant’s invention where the gap is created by the space taken up by reinforcing element (136) between inner tube (210) and outer tube (225).
In response to the applicant’s argument that Beisel fails to disclose a multifilament yarn disposed in the gap, the examiner contends that this argument is moot. Beisel is only relied upon to teach a multifilament yarn and is not relied upon to teach the gap as this structure is already taught by Martins. For the record, Beisel does teach an inner tube (36) surrounded by an outer tube (44) with a reinforcing means (42a, 42b) in between (that space being a gap in the same manner that applicant discloses a gap).
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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