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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3 June 2026 has been entered.
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) 1-5, 7-14, 18-20, 22, and 24 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by US Pre-Grant Publication 2021 to Scherich et al. (Scherich).
Regarding claim 1, Scherich teaches a vascular access system (36, Fig. 1C) comprising an adapter (adapter of 38), a body (body of 38 between 40 and 42) having first (42) and second (40) ends, a primary lumen (extending downward from 48), a primary lumen port (at the end of tubing opposite 54), a secondary lumen (part of 22 housing/receiving tubing 16), a secondary lumen port (14), and a mid-line lumen (22) with a retracted position (Fig. 2A) and an extended position (Figs. 1C-1D). Regarding claim 15, Scherich teaches a flow path (through 12 to adapter 54 which is open to the primary catheter) through the secondary lumen through the primary catheter is open in a retracted position of the mid-line catheter (Fig. 1A) and closed (by 58) in the retracted position (Fig. 1E). Scherich teaches that the primary lumen and the secondary lumen are in fluid communication via a joining connector (12) comprising a seal (inner diameter 56 of the distal connector 12) through which flow passes in the retracted position and to which the midline lumen engages for sealing in the extended position.
Regarding claim 4, Scherich teaches a side port (52) and a joining connector (small diameter portion of port 52 in contact with tubing 50).
Regarding claim 5, Scherich teaches intermediate tubing (50).
Regarding claim 7, Scherich teaches that the joining connector may be permanently connected to the first and second lumens.
Regarding claim 8, Scherich teaches that the joining connector may be permanently connected to the first and second lumens and the secondary lumen (16) are joined to the joining connector (50) by a connector (54).
Regarding claim 9, Scherich teaches that the joining connector (small diameter portion of 52 in contact with tubing 50) is needleless.
Regarding claim 10, as shown in Fig. 1C, Sherich teaches that the longitudinal axis of the secondary lumen (16) is configured to be coaxially aligned with a longitudinal axis of the intermediate tubing (50) and the side port (52).
Regarding claim 11, Scherich teaches that the joining connector (small diameter portion of 52 in contact with tubing 50) is needleless, as is a second connector (14).
Regarding claim 12, Scherich teaches a blood collection device (32, see paragraph 53).
Regarding claim 13, in an alternate interpretation, Scherich teaches a joining connector (54) and a connector (50).
Regarding claim 14, inasmuch as the first catheter is a flexible element, the first catheter is configured to be at least partially aligned in parallel with the secondary lumen (16)
Regarding claim 18, Scherich teaches a tapered portion (58 may be wedge shaped, see paragraph 50) engaging the seal.
Regarding claim 19, Scherich teaches a joining connector (12) and a seal (58).
Regarding claim 20, Scherich teaches a connector (12) with the seal actuator (58) therein which moves to close a path through the secondary lumen to the primary catheter.
Regarding claim 22, Scherich teaches an opening (into 54) at the distal end of the primary catheter.
Regarding claim 24, Scherich teaches attaching a fluid source (32, see paragraph 47), moving the mid-line lumen to the extended position (as shown in Fig. 1C), and delivering the fluid through the mid-line lumen (see again paragraph 47).
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) 6 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherich.
Regarding claim 6, Scherich teaches the limitations of claim 4 from which claim 6 depends as discussed above but does not teach an integrally formed joining connector. It has been held that merely making elements integral does not confer a patentable distinction on the claimed invention relative to prior art which is separate. See MPEP 2144.04 V. B. Accordingly, it would have been obvious at the time of the effective filing date of the application to provide the joining connector integrally with the adapter body of Scherich.
Regarding claim 23, Scherich teaches attaching a blood collection device (32) and moving the mid-line lumen to the extended position (as shown in Fig. 1C). Those of ordinary skill in the art will appreciate that collected blood would be removed for testing in a medical environment. Thus, one of ordinary skill would understand Scherich to imply removing the collection device from the secondary lumen port.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherich in view of US Pre-Grant Publication 2020/0316346 to Burkholz et al. (Burkholz).
Regarding claim 2, Scherich teaches the limitations of claim 1 from which claim 2 depends, as discussed above. Scherich does not teach an advancement member. Burkholz teaches another catheter apparatus generally, and particularly teaches an advancement member (outer section of 107, see Figs. 6A-6B) graspable to move a mid-line lumen (102) to an extended position (paragraph 109). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use an advancement member as taught by Burkholz with the mid-line lumen of Scherich in order to allow a user to move the mid-line lumen manually.
Regarding claim 21, Scherich teaches the limitations of claim 1 from which claim 21 depends, as discussed above. Scherich does not teach a slit. Burkholz teaches a slit (124) having an open position and a closed position depending on the curvature of the catheter which allows for fluid passage depending on the curvature of the catheter. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a slit as taught by Burkholz to the catheter of Scherich in order to allow fluid passage depending on a current curvature of the catheter.
Regarding claim 3, Burkholz teaches that the graspable portion of the advancement member is entirely outside the secondary lumen (see Fig. 6A, noting that the portion of 107 referred to as the advancement member is simply the graspable tabs at the outer end thereof).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scherich in view of Cao et al. (Cao).
Regarding claim 17, Scherich teaches the limitations of claim 16 as discussed above, as well as first and second portions of the mid-line lumen (arbitrarily chosen). Scherich does not teach that the material and stiffness differ between the first and second dportions. Cao teaches another vascular access system generally, and particularly teaches that a lumen (10) with a first material (12, paragraph 19) and a second portion with a second material (10, see paragraphs 18-19) which is stiffer than the first. Cao teaches that this provides varying degrees of flexibility and kink resistance. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use distinct materials as taught by Cao in the access system of Scherich in order to provide varying flexibility and kink resistance.
Response to Arguments
Applicant’s arguments, see page 7, filed 3 June 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 as anticipated over Burkholz have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, the ground(s) of rejection made in view of Scherich is clarified and expanded.
With respect to applicant’s argument that the seal is not shown by Scherich, the examiner disagrees. In particular, applicant alleges that “under the examiner’s characterization, a portion of the mid-line lumen… is the seal, and cannot constitute the mid-line lumen being ‘movable through the seal’… as claimed.” This mischaracterizes the examiner’s position. Specifically, in the examiner’s interpretation, the distal connector (12) of Scherich primarily corresponds to the “joining connector” of claim 1, and the inner circumference (at least at the contact points with flange 58) forms the claimed seal. There is therefore no inconsistency in finding that the mid-line lumen (22) can extend through the seal and through the joining connector, since this is explicitly illustrated in Fig. 1E. Additionally, the examiner finds no reason that the distal connector cannot be considered to partly comprise the seal. Finally, the examiner notes that the “flow path” is the only element operatively linked to the “through the seal” clause. Since a flow path indeed spans from the secondary lumen to the primary catheter through that seal, the limitations of claim 1 are anticipated by Scherich.
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 23 July 2026
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