DETAILED ACTION
Response to Amendment
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/3/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 6-8 and 17-19 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.
In regard to claims 6-7 and 17-18, it is unclear if the power source introduced in these claims are the same power source already recited in the independent claims. For the purposes of this action, the examiner is interpreting the power sources as referencing the same structure and requests that the applicant amend the antecedent basis accordingly. Claims 8 and 19 are rejected by virtue of their dependency on the rejected claims.
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, 9-10, 12, 16-18, 20-21, 23-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cohen et al. (US 2015/0165185; hereafter Cohen).
In regard to claims 1 and 12, Cohen discloses an infusion system (see Fig. 1a) for in-line disinfection of a prepared infusate with ultraviolet ("UV") light (see at least Abstract), the infusion system comprising: a vascular access device ("VAD") (see Fig. 1a) including: an intracorporeal conduit (52) configured to be percutaneously inserted into a patient (see at least par. [0023]); one or more extracorporeal conduits (42) fluidly connected to the intracorporeal conduit (see at least par. [0023]), the extracorporeal conduit configured to remain outside a body of the patient (see Fig. 1a and par. [0023]); a hub (10) between a distal portion of the intracorporeal conduit and one or more respective distal portions of the one-or-more extracorporeal conduits; and one or more respective connectors (40) of the one-or-more extracorporeal conduits (see par. [0023]0; and a UV light ring (12, 16; see Fig. 1b) powered by a power source (14) to emit the UV light (see at least par. [0025]-[0028]), the UV light ring encircling a portion of an infusion lumen of the VAD (see Fig. 1b; the circuitry and LED’s form a ring for irradiating the fluid within the lumen) and irradiate the prepared infusate within the infusion lumen with the UV light for infusing a disinfected infusate into a patient during an infusion of the patient (see par. [0022]-[0029]), the UV light ring incorporated into a luminal surface of the VAD (see Fig. 1b and par. [0022]-[0029]).
In regard to claims 5 and 16, Muse discloses wherein the UV light ring (12, 16) is integrated into a luminal surface of the intracorporeal conduit, a hub conduit of one or more hub conduits respectively fluidly connecting the one-or-more extracorporeal conduits to the intracorporeal conduit, or a connector of the one- or-more connectors (connector 10 can be considered as a connector or hub or part of the intracorporeal conduit; also see par. [0029]; the features can be incorporated into any of the structures).
In regard to claims 6 and 17, Muse discloses the VAD further comprising a fixed or removable internal power source and electronic circuitry (14; see 112 rejection above) between the internal power source and the UV light ring configured to supply power to the UV light ring from the internal power source (see par. [0025]-[0028]).
In regard to claims 7 and 18, Muse discloses further comprising an electrical cable (16) configured to connect to an external power source and electronic circuitry between the electrical cable and the UV light ring to supply power to the UV light ring (see par. [0025]-[0028]).
In regard to claims 9 and 20, Muse discloses wherein the UV light ring is configured to automatically emit the UV light upon an activation event selected from an assembly step while assembling the VAD, a connecting step while connecting the VAD to an infusion bag containing the prepared infusate, or an initiating step of infusing the prepared infusate into the patient through the infusion lumen (see par. [0026]-[0027]).
In regard to claims 10 and 21, Muse discloses wherein the VAD is a catheter, the intracorporeal conduit, the one-or-more extracorporeal conduits, the hub, and the one-or-more connectors being a catheter tube, one or more extension legs, a catheter hub, and one or more Luer connectors, respectively (see Fig. 1b and highlighted portions above).
In regard to claims 23 and 27, Muse discloses wherein the UV light ring is integrated into a luminal surface of the intracorporeal conduit (see par. [0029]).
In regard to claim 24 and 28, Muse discloses wherein the UV light ring is integrated into a luminal surface of an extracorporeal conduit of the one-or-more extracorporeal conduits (see par. [0029]).
In regard to claim 25, Muse discloses, wherein the UV light ring is integrated into a luminal surface of a hub conduit of one or more hub conduits respectively fluidly connecting the one-or-more extracorporeal conduits to the intracorporeal conduit, or a connector of the one-or-more connectors (see Fig. 1a, 1b; see par. [0029]).
In regard to claim 26, Muse discloses wherein the UV light ring is integrated into a luminal surface of a connector of the one-or-more connectors (10 is a connector).
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) 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of Alwan (US 2013/0323119).
In regard to claims 8 and 19, Cohen fails to expressly disclose further comprising an indicator light operably connected to the electronic circuitry, the indicator light configured to emit visible light when the UV light ring emits the UV light.
In a similar art, Alwan discloses that the system 140 comprises a visual indicator, for example the indicator light 143, that indicates that the system 140 has recently been activated (see par. [0045]).
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 system of Cohen with the visual indicator of Alwan in order to provide a visual indicator that the system is in use.
Allowable Subject Matter
Claims 11 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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