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 .
Response to Amendment
The Amendment filed on 6/16/2026 has been entered. Claims 1-10 and 12-20 remain pending in the application. Claims 5-6, 9-10, 13-16, and 20 have been withdrawn from further consideration as detailed in the Non-final Office Action mailed 2/19/2026.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 2/19/2026.
Applicants amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 2/19/2026.
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.
Claims 1-4, 12, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Devgon (U.S. PG publication 20170216564).
In regard to claim 1,
Devgon discloses a fluid transfer device (figure 4 and 5, item 200) for use with peripheral intravenous catheters (PIVCs) (Examiner notes “for use with peripheral intravenous catheters (PIVCs)” is a functional limitation. The fluid transfer device is fully capable of the recited function due to its structure as supported by paragraph [0001], [0057], and [0078]. The PIVCs are not positively required), the fluid transfer device comprising:
an introducer body (figure 5, item 210, 265, and 269) having a proximal end (end formed by item 269) and a distal end (distal most end of item 216);
a flow tube (figure 5, item 260) at least partially housed within the introducer body (see figure 5, paragraph [0060]), wherein the flow tube is configured to be selectively extendable from the introducer body (paragraph [0060] and [0072]); and
a lever lock (figure 4 and 5, item 240) coupled to the distal end of the introducer body (see figure 4; paragraph [0073]), wherein the lever lock includes a lumen configured to allow the flow tube to pass therethrough (paragraph [0073] and [0079]; Examiner notes “configured to allow the flow tube to pass therethrough” is a functional limitation. The lumen is fully capable of the recited function due to its structure), and wherein an effective length of the lever lock relative to the distal end of the introducer body is adjustable by linear movement to enable the fluid transfer device to be configured for use with indwelling catheters of the PIVCs having various lengths (Examiner notes “to enable the fluid transfer device to be configured for use with indwelling catheters of the PIVCs having various lengths” is a functional limitation. As noted above, the PIVCs are not positively required and therefore indwelling catheters of the PIVCs having various lengths are not positively required. The lever lock is attached to the distal end of the introducer body via a threaded connection as disclosed in paragraph [0073], see also figure 5 and 29. Therefore, an effective length of the lever lock relative to the distal end of the introducer body is adjustable by linear movement via the threaded connection to enable the fluid transfer device to be configured for use with indwelling catheters of the PIVCs having various lengths. Examiner notes the claim does not require an effective length of the lever lock relative to the distal end of the introducer body to be adjustable only by linear movement. When the lever lock is adjusted via the threaded connection, it is moved in the linear direction as it is moved up or down on the threads).
In regard to claim 2,
Devgon discloses the fluid transfer device of claim 1, wherein the lever lock comprises an elongated coupler portion (figure 5, item 241), a pair of deflectable arms (figure 5, item 243 and 250; paragraph [0078]), and a blunt cannula (figure 5, item 242).
In regard to claim 3,
Devgon discloses the fluid transfer device of claim 2, wherein the pair of deflectable arms are configured to releasably couple the lever lock to a hub of a catheter adapter of the PIVCs (Examiner notes “configured to releasably couple the lever lock to a hub of a catheter adapter of the PIVCs” is a functional limitation. The hub of a catheter adapter of the PIVCs is not positively required. The pair of deflectable arms are fully capable of the recited function due to their structure and as supported by paragraph [0078]).
In regard to claim 4,
Devgon discloses the fluid transfer device of claim 2, wherein at least a portion of the elongated coupler portion is configured to be slidable within at least a distal portion (figure 4, item 212 and 216) of the introducer body (paragraph [0073]; Examiner notes “configured to be slidable within at least a distal portion of the introducer body” is a functional limitation. At least a portion of the elongated coupler portion is fully capable of the recited function due to its structure and threaded engagement with item 216).
In regard to claim 12,
Devgon discloses the fluid transfer device of claim 1, wherein the proximal end of the introducer body comprises a threaded interface (see figure 4, item 269 wherein threads are present).
In regard to claim 17,
Devgon discloses a fluid transfer device (figure 4 and 5, item 200) for use with peripheral intravenous catheters (PIVCs) (Examiner notes “for use with peripheral intravenous catheters (PIVCs)” is a functional limitation. The fluid transfer device is fully capable of the recited function due to its structure as supported by paragraph [0001], [0057], and [0078]. The PIVCs are not positively required), the fluid transfer device comprising:
an introducer body (figure 5, item 210, 265, and 269) having a proximal end (end formed by item 269) and a distal end (distal most end of item 216);
a flow tube (figure 5, item 260) at least partially housed within the introducer body (see figure 5, paragraph [0060]), wherein the flow tube is configured to be selectively extendable from the introducer body (paragraph [0060] and [0072]); and
a lever lock (figure 4 and 5, item 240) coupled to the distal end of the introducer body (see figure 4; paragraph [0073]), wherein the lever lock comprises an elongated coupler portion (figure 5, item 241), and further wherein the elongated coupler portion of the lever lock is telescopically slidable by linear movement within at least a distal portion (figure 4, item 216 and 212) of the introducer body to enable the fluid transfer device to be configured for use with indwelling catheters of the PIVCs having various lengths (Examiner notes “to enable the fluid transfer device to be configured for use with indwelling catheters of the PIVCs having various lengths” is a functional limitation. As noted above, the PIVCs are not positively required and therefore indwelling catheters of the PIVCs having various lengths are not positively required. The elongated coupler portion of the lever lock is attached to the distal portion of the introducer body via a threaded connection as disclosed in paragraph [0073], see also figure 5 and 29. Therefore, the elongated coupler portion of the lever lock is telescopically slidable by linear movement within at least a distal portion of the introducer body via the threaded connection to enable the fluid transfer device to be configured for use with indwelling catheters of the PIVCs having various lengths. Examiner notes the claim does not require the elongated coupler portion of the lever lock to be telescopically slidable only by linear movement. When the lever lock is adjusted via the threaded connection, it is moved in the linear direction as it is moved up or down on the threads
In regard to claim 18,
Devgon discloses the fluid transfer device of claim 17, wherein the lever lock further comprises a pair of deflectable arms (figure 5, item 243 and 250; paragraph [0078]) and a blunt cannula (figure 5, item 242), and wherein the pair of deflectable arms are configured to releasably couple the lever lock to a hub of a catheter adapter of the PIVCs (Examiner notes “configured to releasably couple the lever lock to a hub of a catheter adapter of the PIVCs” is a functional limitation. The hub of a catheter adapter of the PIVCs is not positively required. The pair of deflectable arms are fully capable of the recited function due to their structure and as supported by paragraph [0078]).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Devgon (U.S. PG publication 20180317830). For clarity purposes Devgon (U.S. PG publication 20180317830) will be referred to as Devgon830.
In regard to claim 1,
Devgon830 discloses a fluid transfer device (see all of figure 55) for use with a peripheral intravenous catheters (PIVCs) (Examiner notes “for use with a peripheral intravenous catheters (PIVCs)” is a functional limitation. The fluid transfer device is fully capable of the recited function due to its structure as supported by paragraph [0008] and [0154]. The PIVCs are not positively required), the fluid transfer device comprising:
an introducer body (figure 54 and 55, item 15160) having a proximal end (end opposite item 15162) and a distal end (figure 54, item 15162);
a flow tube (figure 54 and 55, item 15180; paragraph [0171]) at least partially housed within the introducer body (see figure 54 and 55), wherein the flow tube is configured to be selectively extendable from the introducer body (see figure 54 and [0172]); and
a lever lock (figure 55 and 65, item 15131 and 15150) coupled to the distal end of the introducer body (see figure 55), wherein the lever lock includes a lumen (see figure 55) configured to allow the flow tube to pass therethrough (Examiner notes “configured to allow the flow tube to pass therethrough” is a functional limitation. The lumen is fully capable of the recited function due to its structure), and wherein an effective length of the lever lock relative to the distal end of the introducer body is adjustable by linear movement to enable use of the fluid transfer device to be configured for use with indwelling catheters of the PIVCs having various lengths (see position of the lever lock relative to item 15160 in figure 65 compared to figure 55; Examiner notes “configured for use with indwelling catheters of the PIVCs having various lengths” is a functional limitation. As noted above, the PIVCs are not positively required and therefore indwelling catheters of the PIVCs having various lengths are not positively required. The lever lock is movable relative to the distal end of the introducer body as disclosed in paragraph [0188]-[0189] and as seen in figure 65 compared to figure 55. Therefore, an effective length of the lever lock relative to the distal end of the introducer body is adjustable by linear movement to enable use of the fluid transfer device to be configured for use with indwelling catheters of the PIVCs having various lengths).
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.
Claims 2-3, and 7-8 rejected under 35 U.S.C. 103 as being unpatentable over Devgon830 (U.S. PG publication 20180317830), and further in view of Devgon (U.S. PG publication 20170216564). For clarity purposes Devgon (U.S. PG publication 20180317830) will be referred to as Devgon830.
In regard to claim 2,
Devgon830 discloses the fluid transfer device of claim 1, wherein the lever lock (figure 55 and 65, item 15131 and 15150) comprises an elongated coupler portion (item 15150).
Devgon830 fails to disclose wherein the lever lock comprises a pair of deflectable arms, and a blunt cannula.
Devgon teaches wherein the lever lock (figure 5, item 210 and 240) comprises a pair of deflectable arms (figure 5, item 243 and 250), and a blunt cannula (figure 5, item 242).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Devgon830 to substitute item 240 of Devgon in place of item 15131 of Devgon830, as taught by Devgon, because the substitution is a simple substitution that would yield the same predictable result of enabling attachment to a PIVC (paragraph [0078] of Devgon and paragraph [0154], [0158] and [0008] of Devgon830). Furthermore, Devgon830 discloses modifications can be made to the locking mechanism 15131 (paragraph [0089] and [0158]). Examiner notes item 15150 of Devgon830 would also be modified accordingly to couple to item 240 of Devgon)
In regard to claim 3,
Devgon830 in view of Devgon teaches the fluid transfer device of claim 2, wherein the pair of deflectable arms are configured to releasably couple the lever lock to a hub of a catheter adapter of the PIVCs (Examiner notes “configured to releasably couple the lever lock to a hub of a catheter adapter of the PIVCs” is a functional limitation. The hub of a catheter adapter of the PIVCs is not positively required. The pair of deflectable arms are fully capable of the recited function due to their structure and as supported by paragraph [0078] of Devgon).
In regard to claim 7,
Devgon830 in view of Devgon teaches the fluid transfer device of claim 2, further comprising a spring-biased pin (figure 55, item 15164 of Devgon830; paragraph [0222] of Devgon830) coupled to the elongated coupler portion of the lever lock (see figure 55 of Devgon830).
In regard to claim 8,
Devgon830 in view of Devgon teaches the fluid transfer device of claim 7, wherein the introducer body further comprises at least two openings (first opening which item 15164 of Devgon830 is in on one side of item 15158 of Devgon830 as shown in figure 55 of Devgon830 and second opening which item 15164 of Devgon830 is in on the other side of item 15158 of Devgon830 as shown in figure 63 of Devgon830) formed therein (see figure 55 of Devgon830), and wherein the spring-biased pin coupled to the elongated coupler portion of the lever lock is configured to selectively engage with the at least two openings of the introducer body (see figure 55 and 63 of Devgon830; paragraph [0188] of Devgon830).
Allowable Subject Matter
Claim 19 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claim 19,
The prior art of record does not teach or otherwise render obvious before the effective filing date of the claimed invention in combination with all claim limitations the fluid transfer device of claim 17, further comprising a spring-biased pin coupled to the elongated coupler portion of the lever lock, wherein the introducer body further comprises at least two openings formed therein, and wherein the spring-biased pin coupled to the elongated coupler portion of the lever lock is configured to selectively engage with the at least two openings of the introducer body. Devgon (U.S. PG publication 20170216564) fails to disclose a spring-biased pin coupled to the elongated coupler portion of the lever lock, wherein the introducer body further comprises at least two openings formed therein, and wherein the spring-biased pin coupled to the elongated coupler portion of the lever lock is configured to selectively engage with the at least two openings of the introducer body. No motivation appears to be present to modify Devgon to teach the limitations of claim 19. Additionally, Devgon830 (U.S. PG publication 20180317830) fails to disclose the limitations of claim 17, as the elongated coupler portion (item 15150) of the lever lock (figure 55 and 65, item 15131 and 15150) is not telescopically slidable within at least a distal portion of the introducer body (figure 55 and 65, item 15160). As Devgon830 fails to disclose the limitations of claim 17, Devgon830 fails to disclose the limitations of claim 19 which claim 17 depends on.
Response to Arguments
Applicant's arguments filed 6/16/2026 have been fully considered but they are not persuasive. Applicant argues Devgon (U.S. PG publication 20170216564) and Devgon830 (U.S. PG publication 20180317830) do not disclose the arrangement of the amended claims. No specific arguments have been included as to why Applicant believes Devgon and Devgon830 do not disclose the amended limitations. As detailed above, Devgon does disclose the limitations of amended claim 1 and claim 17 and Devgon830 does disclose the limitations of amended claim 1. No other specific arguments have been provided.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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