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 .
Election/Restrictions
Applicant’s election without traverse of (Group I and Species A) in the reply filed on 12/1/2025 is acknowledged.
Claims 9, 13, and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/1/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/25/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 6-8 and 12 are objected to because of the following informalities:
On line 1 of claim 6, “may comprise” should read “comprises” because the applicant should avoid using conditional terms. For the purposes of this action, the latter interpretation is being applied and the examiner is assuming that the recited yarn comprises at least one of the recited materials.
On line 1 of claim 7, “the multifilament” should read “the multifilament yarn” to correct a minor antecedent basis issue.
On line 1 of claim 8, “the multifilament” should read “the multifilament yarn” to correct a minor antecedent basis issue.
On line 2 of claim 12, “a braid” should read “the braid” to correct a minor antecedent basis issue.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8, 10-12, and 14-16 are rejected under 35 U.S.C. 101 the claims recite the human body.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-8, 10-12, and 14-16 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Limitations such as “a port implanted in a patient” (see line 2 of claim 1) and “a catheter implanted in the patient” (see line 3 of claim 1) positively recite the patient by reciting that the device is actively implanted in the patient. Similar limitations appear in other claims 2, 4, 11 and 15. The examiner suggests amending “implanted” to “implantable” or “configured to be implanted” to recite a functional limitation without positively reciting the human body.
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.
Claim(s) 1-3 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martins et al. (US 2001/0016730; hereafter Martins).
In regard to claim 1, Martins discloses a fluid system comprising: a port (86) implanted in a patient (see par. [0009], [0092], [0094]); and a catheter (100) 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 (210; see at least Fig. 22), a second tubing (225; see at least Fig. 22), 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 2, Martins discloses wherein the catheter is implanted 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 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]).
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) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Martins 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) 5-7, 11, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Martins in view of Beisel (US 5,947,940).
In regard to claim 5, 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 5.
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 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 In regard to claim 11, Martins discloses a fluid system comprising: a port (86) implanted in a patient (see par. [0009], [0092], [0094]); and a catheter (100) 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 (210; see at least Fig. 22), a second tubing (225; see at least Fig. 22), 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), 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 implanted 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]).
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See 892.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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