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 with traverse of Species D in the reply filed on 1/26/2026 is acknowledged. The traversal is on the ground(s) that the species are sufficiently related that no serious burden of search is required. This is not found persuasive because, the inventions materially differing in configuration of valve mechanism warrant diverging searches. In the instant case, the elected invention requires a slide type valve classified in A61M2039/224 where the other inventions not being drawn to this type of valve would warrant diverging searches such as A61M2039/229; 2039/248 for example and text searches therein. The Examiner further notes that consideration of different prior art amounts to a serious burden where it is clear that the closest relevant reference to the elected embodiment does not necessarily anticipate non-elected claims. Thus, additional art must be considered when determining the patentability of the non-elected claims amounting to a serious burden on the Examiner.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3, 8, 10-17, 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/17/2023.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “actuable valve” is objected to be the Applicant appears referring to “actuatable valve” as consistent with claim 6. Appropriate correction is required.
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 9 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.
Regarding claim 9, the limitation “substantially equivalent” renders the claim indefinite because its unclear what tolerance allowed for variation in the lumens lines. The specification merely nominally recites the term without any explanation and thus its unclear how much variation within the claimed lines is allowed and still infringe on the climaed scope.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4-7, 18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jadhav US 2023/0057569.
Regarding claim 1, Jadhav discloses an intravascular catheter assembly, see fig.1, comprising: a catheter adapter 50, comprising: a distal end 54; a proximal end 56; a first lumen, see para. [0039], arranged between and in fluid communication with the distal end and the proximal end; a catheter 58 arranged at the distal end of the catheter adapter and in fluid communication with the lumen, id.; and a first side port 59, 70 in fluid communication with the lumen; a first fluid conduit 60 having a distal end 59 and a proximal end, the side connected to element 59, 70, the distal end 59 of the fluid conduit coupled to the side port, the distal end is fluidly coupled to the side port since fluid flows through the whole line; and a connector 110 comprising a proximal end 112, a distal end 114 connected to the fluid conduit and a second lumen 120, 118 therethrough, the connector comprising an actuable valve 124.
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Regarding claim 2, referring to the annotated figure above, Jadhav discloses the valve is arranged at the proximal end of the connector. For the purposes of claim 2, the connector is interpreted as the entire box labeled above, where the valve 124 is connected at the proximal end of the connector assembly.
Regarding claim 4, referring to figs. 7-9, Jadhav discloses the valve 110 comprises a sliding mechanism 124 configured to displace a portion of the second lumen, the portion labeled 125, such that the portion of the second lumen has a longitudinal axis that is offset from a longitudinal axis of the second lumen, see fig. 7, the longitudinal axis running through the second lumen 118, 120 is offset from the longitudinal axis of 125.
Regarding claim 5, Jadhav discloses the connector is a y-connector as seen in the annotated figure above.
Regarding claim 6, Jadhav discloses the valve is at least one of manually and remotely actuatable. See para. [0034] stating that the user applies an axial force by pressing or pushing the slider, i.e. manually actuatable.
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Regarding claim 7, Jadhav discloses a second fluid conduit 40 extending from the connector.
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Regarding claim 9, Jadhav discloses the second lumen has an inner diameter substantially equivalent to an inner diameter of the first fluid conduit and the second fluid conduit. As best understood, Jadhav shows the first fluid conduit 60 and the second fluid conduit having generally similar inner diameters. Referring to fig. 2b, the inner lumen 126 and 120 have substantially similar diameters to the devices connected to it and thus are interpreted as substantially equivalent.
Regarding claim 18, Jadhav discloses a needless access connector coupled to the connector. The downstream end 112 is connected to a collection device and another needleless connector 70 is attached via needless access connectors n1, n2.
Claim(s) 1, 5-7, 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lampropoulos US 2006/0155247 hereinafter “LAMP”.
Regarding claim 1, Lamp discloses an intravascular catheter assembly, see fig. 2a, comprising: a catheter adapter 102, comprising: a distal end, 100; a proximal end 106; a first lumen, see para. [0030] stating that the side port feeds the main lumen and the sheath 110 has a lumen for a catheter, arranged between and in fluid communication with the distal end and the proximal end; a catheter, id. stating the catheter is accepted into the sheath 110, arranged at the distal end of the catheter adapter and in fluid communication with the lumen, id. the main lumen allows passages of the materials into the patient through the sheath; and a first side port 112, 237 in fluid communication with the lumen; a first fluid conduit 120 having a distal end, connected at 112, and a proximal end, connected at element 240, the distal end of the fluid conduit coupled to the side port, the distal end is fluidly coupled to the side port since fluid flows through the whole line; and a connector, shown at 230, comprising a proximal end, the side shown at 240b in fig. 3a, a distal end, the side shown at 240a in fig. 3a, connected to the fluid conduit and a second lumen, the fluid passage through connector 230 therethrough, the connector comprising an actuable valve 235.
Regarding claim 5, Lamp discloses the connector is at least one of a t-connector and a y-connector. See fig. 3a showing a t-connector.
Regarding claim 6, Lamp discloses the valve is manually actuatable. See fig. 2c showing a hand to operate the valve.
Regarding claim 7, Lamp discloses a second fluid conduit extending from the connector. See fig. 2a, element 125.
Regarding claim 9, as best understood, Lamp discloses the second lumen has an inner diameter substantially equivalent to an inner diameter of the first fluid conduit and the second fluid conduit. The first and second fluid conduits are shown to be substantially identical in fig. 3a where the second lumen shown in fig. 4 is interpreted as substantially equivalent thereto.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD LUTHER SUNG whose telephone number is (571)270-3765. The examiner can normally be reached 9-5 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at (571)272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GERALD L SUNG/Primary Examiner, Art Unit 3741