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 .
Amendment Entered
This Office action is responsive to the Amendment filed on February 24th, 2026. The examiner acknowledges the amendments to claims 21. Claims 21-26 remain pending in the application.
Response to Arguments
Applicant’s arguments and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections under 35 U.S.C. 112(b) are withdrawn. However additional rejections are added in view of the amendments.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 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.
Claim Objections
Claims 22-26 are objected to because of the following informalities:
Regarding claim 22 “the system of claim 0” in line 1 should recite “the system of claim 21”;
Regarding claim 23 “the system of claim 0” in line 1 should recite “the system of claim 21”;
Regarding claim 24 “the system of claim 0” in line 1 should recite “the system of claim 21”;
Regarding claim 25 “the system of claim 0” in line 1 should recite “the system of claim 24”;
Regarding claim 26 “the system of claim 0” in line 1 should recite “the system of claim 26”.
Appropriate correction is required.
Examiner note: For examination purposes, the Examiner is interpreting that the dependent claims are maintaining the same dependencies as the claims filed 7/28/25.
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 21-26 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.
Claim 21 (Claims 22-26 by virtue of dependency) recites the limitation "connect with a collection adapter " in line 8. It is unclear if the collection adapter is in addition to or referring to the same collection adapter recited in line 3. For examination purposes it will be interpreted as referring to the same collection adapter and the limitation is suggested to recite “the collection adapter”.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Truitt (US 20060089603 A1 – previously cited) in view of Whelan (US 20150144224 A1), further in view of Yan (US 20230397859 A1 – previously cited), and further in view of Young (US 4192303 A – previously cited).
Regarding claim 21, Truitt discloses a system (“intravenous system”, para. [0003], fig. 1B) comprising: a syringe (“fluid transfer device … syringe”, para. [0035, 0077, 0082], fig. 1B); a collection adapter (third fluid transfer device 103, fig. 1B & “standard fluid transfer devices (e.g., intravenous tube, syringe, catheter or other connector”, para. [0035]); a three-way connector (fluid control device 2, figs. 1A-1B) comprising: a first connector (first port 6, figs. 1a-1B) configured to (Examiner’s Note: functional language, i.e., capable of) connect with a fluid channel (first fluid transfer device 100 (intravenous tube, catheter) connected to the first port, para. [0082]); a second connector (second port 8, figs. 1A-1B) configured to (Examiner’s Note: functional language, i.e., capable of) connect with the syringe (second fluid transfer device 102 (syringe) may be connected to the second port 8, para. [0082]) to allow a fluid to be drawn from the fluid channel into the syringe (fluid may flow from … port 6 … into port 8 … into … 102, para. [0087]); and a third connector (third port 10, figs. 1A-1B) configured to (Examiner’s Note: functional language, i.e., capable of) connect with a collection adaptor (third fluid transfer device 103 (other connector) may be connected to a third port 10, para. [0082]); and a valve (valve element 16, fig. 2B, “second valve element”, para. [0040]).
Truitt does not disclose wherein the collection adaptor has a shape comprising a first diameter closest to the three-way connector, a second diameter further from the first diameter and larger than the first diameter, and a third diameter further from the second diameter and larger than the second diameter, the shape facilitating directly receiving different sized collection devices.
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Whelan, annotated Fig. 2
However, Whelan directed to a sampling port discloses a collection adapter (sampling port 10, figs. 1-7) wherein the collection adaptor has a shape comprising a first diameter closest to the three-way connector (as seen in annotated fig. 4, “one diameter near the base 16 … space portion 33”, para. [0093], as seen in figs. 1-7), a second diameter further from the first diameter and larger than the first diameter (as seen in annotated fig. 4, “larger diameter further away from the base 16 … space portion 35”, para. [0093], as seen in figs. 1-7), and a third diameter further from the second diameter and larger than the second diameter (unlabeled, but as seen in annotated fig. 4, “third space portion at the open end which is of a larger size”; “third space portion 39”, para. [0027, 0093], & figs. 1-7), the shape facilitating directly receiving different sized collection devices (as seen in figs. 5-7, “accommodated … without the need for separate guides”; “adapted to receive … sized … vials having the first size … sized … vials having the second size” para. [0004, 0022-0026, 0094-0095, 0100-0102]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Truitt such that the collection adaptor has a shape comprising a first diameter closest to the three-way connector, a second diameter further from the first diameter and larger than the first diameter, and a third diameter further from the second diameter and larger than the second diameter, the shape facilitating directly receiving different sized collection devices, in view of the teachings of Whelan, as such a modification would have been merely a substitution of the third fluid transfer device of Truitt for the sampling port of Whelan and would aid in accommodating sampling vials having different diameters without the need for separate guides.
Truitt, as modified by Whelan hereinabove, does not expressly disclose the valve, separate from the three-way connector and between the syringe and the collection adaptor.
However, Yan directed to a blood draw system having a valve (second valve 1132, fig. 11, “check valve”, para. [0010]), a three-way connector (first valve 1131, fig. 11, “first valve … three-way stopcock valve”, par. [0010]) and a collection adapter (first blood draw device 1121, fig. 11) discloses the valve (second valve 1132, fig. 11), separate from the three-way connector (first valve 1131, fig. 11) and between the syringe (flush device 1140, fig. 11, “syringe”, para. [0011]) and the collection adaptor (first blood draw device 1121, fig. 11) (as seen in fig. 11). Yan further discloses that the second valve 1132 may be configured to selectively permit fluid communication and that the second valve 1132, may then be moved to closed positions for subsequent steps during a blood draw procedure, as desired (para. [0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Truitt, as modified by Whelan hereinabove, to further comprise the valve, separate from the three-way connector and between the syringe and the collection adaptor, in view of the teachings of Yan, as this would aid in selectively permitting fluid communication between the syringe and the catheter adapter during steps of a blood draw procedure.
Truitt, as modified by Whelan and Yan hereinabove, does not expressly disclose the valve configured to be pushed to an open position and also configured to be released to return to a closed position.
However, Young discloses the valve (valve means comprising a substantially cylindrical plug member, col. 4 line 26, fig. 3) configured to (Examiner’s Note: functional language, i.e., capable of) be pushed to an open position (“open … squeezed”) and also configured to (Examiner’s Note: functional language, i.e., capable of) be released to return to a closed position (“close … released”) (col. 2 lines 13-17 & col. 4 lines 26-46). Young further discloses periodic flushing of the catheter system is accomplished quickly and easily, using only one hand of the person handling the apparatus (col. 6 lines 27-28)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Truitt, as modified by Whelan and Yan hereinabove, to further comprise the valve configured to be pushed to an open position and also configured to be released to return to a closed position, in view of the teachings of Young, as such a modification would have been merely a substitution of the valve of Truitt and would aid in providing periodic flushing of the catheter system quickly and easily, using only one hand of the person handling the apparatus.
Regarding claim 23, Truitt, as modified by Whelan, Yan, and Young hereinabove, discloses the system of claim 21. Truitt, as modified by Whelan, Yan, and Young hereinabove, does not expressly disclose wherein the first connector is connected with the fluid channel and the fluid channel is connected to a patient needle.
However, Yan directed to a blood draw system having a first connector (first connector 1561, para. [0116], fig. 15), a fluid channel (first fluid conduit 1551, para. [0119], fig. 15), and a patient needle (catheter 1571, para. [0117]) discloses wherein the first connector (first connector 1561, para. [0116], fig. 15) is connected with the fluid channel (first fluid conduit 1551, para. [0119], fig. 15) and the fluid channel is connected to a patient needle (catheter 1571, para. [0117]). Yan further discloses the example blood collection set in fig. 15 and that a clean blood sample may then be drawn into the first blood draw device 1521 (para. [0116, 0121]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Truitt, as modified by Whelan, Yan, and Young hereinabove, such that the first connector is connected with the fluid channel and the fluid channel is connected to a patient needle, in view of the teachings of Yan, as this would aid in drawing a clean blood sample.
Regarding claim 24, Truitt, as modified by Whelan, Yan, and Young hereinabove, discloses the system of claim 21, wherein the first connector (first port 6, para. [0040], fig. 2A) is a needleless connector (needleless access device, para. [0040], fig. 2A).
Regarding claim 25, Truitt, as modified by Whelan, Yan, and Young hereinabove, discloses the system of claim 24. Truitt, as modified by Whelan, Yan, and Young hereinabove, does not expressly disclose the system further comprising a collection device.
However, Whelan directed to the sampling port discloses a collection device (vials 50, 60, 70, figs. 5-7).
Upon the modification of Truitt to incorporate the sampling port of Whelan as the third fluid transfer device/collection adapter, as described with respect to claim 21 above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Truitt, as modified by Whelan, Yan, and Young hereinabove, such that the system further comprises a collection device, in view of the teachings of Whelan, as this would aid in allowing a sample of fluid to be withdrawn by incorporating the sampling vials of Whelan (Whelan, para. [0002]).
Regarding claim 26, Truitt, as modified by Whelan, Yan, and Young hereinabove, discloses the system of claim 25. Truitt, as modified by Whelan, Yan, and Young hereinabove, does not expressly disclose wherein the collection device is a vacuum tube.
However, Yan directed to a blood draw system having a collection device (blood draw device 1021/1521, para. [0080, 0116]) discloses wherein the collection device (blood draw device 1021/1521, para. [0080, 0116]) is a vacuum tube (at least one of a syringe and a VACUTAINER®, para. [0080]). Yan further discloses the example blood collection set in fig. 15 and that a clean blood sample may then be drawn into the first blood draw device 1521 (para. [0116, 0121]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Truitt, as modified by Whelan, Yan, and Young hereinabove, such that the collection device is a vacuum tube, in view of the teachings of Yan, as such a modification would have been merely a substitution of the sampling vials of Truitt, as modified by Whelan, Yan, and Young hereinabove, for the VACUTAINER® of Yan and would aid in drawing a blood sample.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Truitt in view of Whelan, Yan, and Young, as applied to claim 21 above, and further in view of Kanno (US 4658655 A – previously cited).
Regarding claim 22, Truitt, as modified by Whelan, Yan, and Young hereinabove, discloses the system of claim 21, and the valve (valve element 16, para. [0040]). Truitt, as modified by Whelan, Yan, and Young hereinabove, does not expressly disclose wherein the valve is configured to be a unidirectional check valve.
However, Kanno directed to a medical device for sampling fluid discloses a valve (valve 32) configured to (Examiner’s Note: functional language, i.e., capable of) be a unidirectional check valve (“check valves … fluid to flow in one direction”; check or nonreturn valves 32, Abstract, co. 4 lines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Truitt, as modified by Whelan, Yan, and Young hereinabove, such that the valve is configured to be a unidirectional check valve, in view of the teachings of Kanno, as this would aid in direction control of the fluid flow and cause the fluid to flow in a single direction.
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 ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached on (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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