FINAL 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 .
This is the second office action on the merits. This office action is in response to the amendment filed on 02/25/2026. Applicant has amended claims 1, 9-11, and 15-16 and canceled claims 14 and 18. Claims 5, 13, and 20 remain withdrawn from further consideration.
Election/Restrictions
Applicant’s amendment to claim 10 necessitates additional claims to be withdrawn, as outlined below. Applicant is reminded of the election of species of Figs. 2-3 and 4-5 in the response filed on 11/26/2025.
Claims 10-12 and 15 are withdrawn as being drawn to a nonelected species.
Regarding claim 10, the limitation “driver, the drive shaft and the syringe are disposed consecutively on a common axis” is not shown in the elected species of Fig. 5. Fig. 5 shows driver 250 and drive shaft 254 being disposed on a different axis from syringe 140. The limitation is believed to be directed to the nonelected species of Fig. 7, which shows driver 250, drive shaft 254 (¶ [0047] of the spec. states that “the drive shaft 254 may be part of the syringe interface 210 or of the driver 250”), and syringe 140 being disposed consecutively on a common axis.
Claims 11-12 and 15 are dependent on claim 10 and are also believed to be directed to the nonelected species of Fig. 7 for the same reasons listed above.
Since the above limitation is not found in the species of Fig. 5, claims 10-12 and 15 are drawn to a nonelected species, and are also withdrawn from further consideration pursuant to 37 CFR 1.142(b).
Claims 1-4, 6-9, 16-17, and 19 are pending and examined.
Claim Objections
Claims 16-17 and 19 are objected to because of the following informalities:
Claim 16, line 8: “the driver” is believed to be in error for --the external driver-- (see claim 16, line 6)
Claim 17, line 2: “the driver” is believed to be in error for --the external driver-- (see claim 16, line 6)
Claim 19, lines 2 and 4: “the driver” (two instances) is believed to be in error for --the external driver-- (see claim 16, line 6)
Appropriate correction is required.
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.
Claims 1-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Vanderveen (US 4,608,042: IDS reference), in view of Andersen (US 2015/0352288 A1).
Regarding claim 1, Vanderveen teaches (Fig. 3) an intravenous (IV) infusion set, comprising:
an infusion component (72);
a first IV tube coupled to a first inlet port (see annotated Fig. 3 on next page) of the infusion component (72);
a second IV tube coupled to an outlet port (see annotated Fig. 3 on next page) of the infusion component (72); and
a syringe interface (see annotated Fig. 3 on next page) coupled to a second inlet port (74) of the infusion component (72), the syringe interface comprising:
a housing (see annotated Fig. 3 on next page) configured to receive a syringe (18);
an outlet port (see annotated Fig. 3 on next page) coupled to (via needle 84) the second inlet port (74) of the infusion component (72); and
a plunger (80).
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However, Vanderveen does not teach the specifics of the syringe interface comprising:
a drive interface coupling configured to receive a drive interface,
wherein the drive interface is configured to be rotated by a driver to slidably move the plunger within a body of the syringe to dispense a fluid from the syringe,
wherein the driver is disposed separately and externally to the housing of the syringe interface.
Andersen teaches (Figs. 2a-3b and 5a-5b) a syringe interface (see annotated Fig. 2a on next page) comprising:
a housing (140 – Figs. 2a-3b) configured to receive a syringe (Fig. 2a: comprising 10 and 13);
an outlet port (12 – Fig. 2a); and
a drive interface coupling (600 – Figs. 2a-3b) configured to receive a drive interface (700),
wherein the drive interface (700) is configured to be rotated by a driver (Figs. 5a-5b: comprising of drive member 500, gear wheels 255 and 505, and dose setting member 250, as well as other components as shown in annotated Fig. 2a on next page) to slidably move a plunger (13 – Fig. 2a) within a body (11 – Fig. 2a) of the syringe (10 and 13) to dispense a fluid (¶ [0065], l. 2: “drug filled cartridge”) from the syringe (10 and 13) – (see ¶ [0086] for a description of how the drive member 500 rotates the drive interface 700 to drive piston rod 800 to move plunger 13),
wherein the driver (250, 255, 500, and 505) is disposed separately and externally to the housing (140) of the syringe interface (as shown in annotated Fig. 2a on next page, the annotated “Driver” is outside of housing 140 – see also Figs. 3a-3b, which shows the driver part 500 being separate and external to housing 140).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace Vanderveen’s syringe interface with Andersen’s syringe interface, because it has been held that a simple substitution of one known element (Andersen’s syringe interface as shown in Andersen, Fig. 2a) for another (Vanderveen’s syringe interface as shown in Vanderveen, Fig. 3) to obtain predictable results (in this case, to provide an improved handheld injection device that includes a dose setting mechanism allowing a user to set a desired dose to be injected, as taught by Andersen, ¶ [0087]) was an obvious extension of prior art teachings, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I)(B).
Regarding claim 2, Vanderveen, in view of Andersen, teaches the invention as claimed and as discussed above for claim 1, and the combination further teaches (Andersen, Figs. 5a-5b) the drive interface (700) is configured to be coupled (via gear wheels 505 and 705) to a drive shaft (500) of the driver (shown in annotated Fig. 2 on previous page) and rotated by the drive shaft (500) of the driver (as described in ¶ [0106]).
Regarding claim 3, Vanderveen, in view of Andersen, teaches the invention as claimed and as discussed above for claim 2, and the combination further teaches (Andersen, Fig. 2a) the drive interface (700) is an integral part of the syringe interface (as shown in annotated Fig. 2a on previous page, drive interface 700 is assembled together with the syringe interface) and the drive shaft (500) is configured to be removably coupled to the driver (shown in annotated Fig. 2a on previous page) – (Fig. 3a shows drive shaft 500 as a removably separate element; Fig. 2a shows drive shaft 500 coupled to the driver).
Regarding claim 4, Vanderveen, in view of Andersen, teaches the invention as claimed and as discussed above for claim 2, and the combination further teaches (Andersen, Fig. 2a) the drive shaft (500) is an integral part of the driver (as shown in annotated Fig. 2a on previous page, drive shaft 500 is assembled together with the driver) and the drive shaft (500) is configured to be removably coupled (via gear wheels 505 and 705 – see Figs. 5a-5b) to the syringe interface (see annotated Fig. 2a on previous page) – (Fig. 3a shows drive shaft 500 as a removably separate element; Fig. 2a shows drive shaft 500 coupled to the driver).
Regarding claim 6, Vanderveen, in view of Andersen, teaches the invention as claimed and as discussed above for claim 1, and the combination further teaches the drive interface (Andersen, 700) is provided as a removable component separated from the rest of the IV infusion set (Vanderveen, Fig. 3) – (Andersen’s Fig. 3a shows drive interface 700 as a removably separate element. When combined with Vanderveen’s IV infusion set, Andersen’s drive interface 700 would also be a removably separate element).
Regarding claim 7, Vanderveen, in view of Andersen, teaches the invention as claimed and as discussed above for claim 1, and the combination further teaches (Andersen, Fig. 2a) the drive interface (700) is a removable component pre-coupled to the syringe interface (see annotated Fig. 2a on previous page) – (Fig. 3a shows drive interface 700 as a removably separate element; Figs. 2a show drive interface 700 pre-coupled to the syringe interface).
Regarding claim 8, Vanderveen, in view of Andersen, teaches the invention as claimed and as discussed above for claim 1, and the combination further teaches (Andersen, Fig. 2a) the outlet port (12) of the syringe interface (as shown in annotated Fig. 2 on previous page) is configured to receive an outlet port of the syringe (bottom end of 10).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Vanderveen (US 4,608,042: IDS reference), in view of Andersen (US 2015/0352288 A1), and in further view of Chelak (US 2019/0275312 A1).
Regarding claim 9, Vanderveen, in view of Andersen, teaches the invention as claimed and as discussed above for claim 1, and Vanderveen further teaches (Fig. 1) the at least one infusion component (70 would be another infusion component) comprises:
a fluid connector (16) configured to be coupled to a fluid container (14).
However, Vanderveen, in view of Andersen, does not teach a luer lock connector configured to be coupled to a catheter inserted into a patient.
Chelak teaches a similar IV infusion set (Fig. 2) comprising at least one infusion component (180) and a syringe interface (connects to 180 – see ¶ [0077], ll. 14-16), and further teaches:
a luer lock connector (164) configured to be coupled (via stabilization body 120) to a catheter (210) inserted into a patient (¶ [0068], ll. 1-3).
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 Vanderveen, in view of Andersen, by including a luer lock connector configured to be coupled to a catheter inserted into a patient, in order to lock the catheter in place, as taught by Chelak (¶ [0068], ll. 5-8).
Claims 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Vanderveen (US 4,608,042: IDS reference), in view of Chelak (US 2019/0275312 A1) and Andersen (US 2015/0352288 A1).
Regarding claim 16, Vanderveen teaches (Fig. 1) a method of using an intravenous (IV) set assembly, the method comprising:
coupling a first end (top end of 16) of an IV set (the IV set shown in Fig. 1) to a fluid container (14);
coupling a second end of the IV set to a patient (where it says “TO PATIENT”);
flowing fluid from the fluid container (14) to the patient (col. 6, ll. 49-50: “infusion of fluids to the patient from fluid source 14”); and
a syringe interface (see annotated Fig. 1 on next page) of the IV set;
placing a syringe (18) containing fluid (col. 3, l. 53: “fluid filled syringe 18”) within a housing (see annotated Fig. 1 on next page) of the syringe interface; and
a plunger (80 – shown in Fig. 3).
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However, Vanderveen does not teach coupling the second end of the IV set to a catheter inserted into the patient.
Chelak teaches a similar IV set (Fig. 2) comprising at least one infusion component (180) and a syringe interface (connects to 180 – see ¶ [0077], ll. 14-16), and further teaches:
coupling a second end (164) of the IV set to a catheter (210) inserted into a patient (¶ [0068], ll. 1-3).
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 Vanderveen by including a catheter, in order to provide regular administration of fluids or medications into the patient, as taught by Chelak (¶ [0004], ll. 1-4), therefore providing:
coupling the second end (Vanderveen, Fig. 1 where it says “TO PATIENT”) of the IV set to a catheter (Chelak, 210) inserted into the patient.
However, Vanderveen, in view of Chelak, does not teach coupling an external driver to a drive interface of the syringe interface of the IV set;
operating the driver externally to the housing to rotate the drive interface of the syringe interface to slidably move the plunger within a body of the syringe; and
dispensing the fluid from the syringe to the patient at a fluid flow rate based on the rotation of the drive interface of the syringe interface.
Andersen teaches (Figs. 2a-3b and 5a-5b) placing a syringe (Fig. 2a: comprising 10 and 13) containing fluid (¶ [0065], l. 2: “drug filled cartridge”) within a housing (140 – Figs. 2a-3b) of a syringe interface (see annotated Fig. 2a on next page), and further teaches:
coupling an external driver (Figs. 5a-5b: comprising of drive member 500, gear wheels 255 and 505, and dose setting member 250, as well as other components as shown in annotated Fig. 2a on next page) to a drive interface (700) of the syringe interface;
operating the driver externally to the housing (140) – (as shown in annotated Fig. 2a on next page, the annotated “Driver” is outside of housing 140 – see also Figs. 3a-3b, which shows the driver part 500 being separate and external to housing 140) to rotate the drive interface (700) of the syringe interface to slidably move a plunger (13 – Fig. 2a) within a body (11 – Fig. 2a) of the syringe (10 and 13) – (see ¶ [0086] for a description of how the drive member 500 rotates the drive interface 700 to drive piston rod 800 to move plunger 13); and
dispensing the fluid from the syringe (10 and 13) to a patient at a fluid flow rate based on the rotation of the drive interface (700) of the syringe interface (¶ [0113], ll. 11-13: “All this time the drive nut 700 rotates to drive forward the piston rod 800 resulting in the expelling of the drug through the attached needle”).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace Vanderveen’s syringe interface with Andersen’s syringe interface, because it has been held that a simple substitution of one known element (Andersen’s syringe interface as shown in Andersen, Fig. 2a) for another (Vanderveen’s syringe interface as shown in Vanderveen, Fig. 3) to obtain predictable results (in this case, to provide an improved handheld injection device that includes a dose setting mechanism allowing a user to set a desired dose to be injected, as taught by Andersen, ¶ [0087]) was an obvious extension of prior art teachings, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I)(B), therefore providing the above method steps as outlined in Andersen.
Regarding claim 17, Vanderveen, in view of Chelak and Andersen, teaches the invention as claimed and as discussed above for claim 16, and the combination further teaches (Andersen, Fig. 2a) operating the driver (see annotated Fig. 2 on previous page) to rotate the drive interface (700) of the syringe interface at one of a fixed speed and a variable speed (per ¶ [0113], the user applies a force on the injection button 300, which releases drive member 500 for rotation, thereby rotating drive nut 700 to drive forward piston rod 800 resulting in the expelling of the drug. ¶ [0114] recites “the expelling may be halted at any time by releasing pressure on the injection button 300. The expelling may be continued by renewed pressing down the injection button 300”).
Regarding claim 19, Vanderveen, in view of Chelak and Andersen, teaches the invention as claimed and as discussed above for claim 16, and the combination further teaches (Andersen, Fig. 5a-5b) coupling a first end of a drive shaft (in this case, it would be the left end of 500) to the driver (in this case, dose control member 350 would act as the driver, as shown in Fig. 3a);
coupling a second end of the drive shaft (right end of 500, where gear wheel 505 is located) to the drive interface (700) of the syringe interface;
and rotating the drive interface (700) via rotation of the drive shaft (500) of the driver (as discussed in ¶ [0086]).
Response to Arguments
Applicant’s arguments regarding the new limitations in claims 1 and 16 have been considered but are moot in view of the new ground(s) of rejection, necessitated by Applicant's amendments. To the extent possible, Applicant's arguments have been addressed in the body of the rejections at the appropriate locations.
Regarding Applicant’s arguments regarding the new limitations in claim 10, it is noted that the amendment to claim 10 renders the claim being drawn to a nonelected species (Fig. 7) as discussed on page 2 of this office action. Therefore, claim 10 and its dependents are not examined because they have been withdrawn as being directed to a nonelected species.
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 HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
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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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/HENRY NG/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
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