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 5/4/2026 has been entered. Claims 1-8 and 10-18 are pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 12/8/2026.
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.
(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) 1-4, 8, 11-12, 14-15, and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bae (KR 20170041393 A).
Regarding claims 1-3, Bae discloses a modular constraint assembly connectable to a tubing set for use in medication delivery (drug delivery device comprising flow-controlled drug dose controller 10 and drug delivery tube 3, [025] and [0028] & Fig. 1) comprising:
a constraint member (flow controlled drug dose controller 10, [0028] & Fig. 3-5) comprising a molded, rigid constraint profile (orifice 16 comprising passage hole 16a, [0041] and [0050] & Fig. 4-5), a distal aperture (second groove portion 16d, [0050] & Fig. 4-5), and a proximal aperture defining a lumen having a first diameter (first groove portion 16b having a diameter, [0050] & Fig. 4-5), where the constraint profile defines a restricted lumen having a second diameter (passage hole 16a defining a lumen having a diameter smaller than the diameter of first groove portion 16b, [0050] & Fig. 4-5);
a distal connector in fluid communication with the distal aperture (second portion 13 having a second passage 13a in communication with orifice 16, [0040]-[0041] & Fig. 4-5); and a proximal connector in fluid communication with the proximal aperture (first portion 12 having a first passage 12a in communication with orifice 16, [0040]-[0041] and [0036] & Fig. 4-5), wherein the distal and proximal connectors are integral to the constraint member (orifice 16, second portion 13, and first portion 12 all being integrally formed of body part 11, [0034]-[0035] and [0040]-[0041] & Fig. 4-5),
wherein the first diameter is greater than the second diameter (diameter of portion 16b is greater than the diameter of passage hole 16a, [0047] and [0050] & Fig. 4-5), and wherein the constraint profile is configured with a predetermined shape to achieve a calibrated flow rate for a fluid medication at a specific concentration and a medication administration temperature (“since the drug introduced into the first passage 12a passes through the through hole 16a of the orifice 16 and passes only a certain amount of the drug, the drug can be controlled to be administered in a predetermined amount by the present invention”, [0041] & Fig. 4-5; “the dose can correspond to the diameter of the through hole 16a of the orifice 16”, [0047]; passage hole 16a configured with a predetermined diameter to achieve a calibrated flow rate, which would necessarily yield a flow rate for a given substance at a given temperature).
Regarding claim 4, Bae discloses all the limitations of claim 1. Bae further discloses the modular constraint assembly wherein the distal and proximal connectors are each connected to flexible tubing connected to the constraint member (first portion 12 operatively connected to flexible drug delivery tube 3, [0005] and [0028] & Fig. 1-2; second portion 13 operatively connected to downstream tubing, see Fig. 14 and [0061]).
Regarding claim 8, Bae discloses all the limitations of claim 1. Bae further discloses the modular constraint assembly wherein the constraint profile is substantially symmetric (passage hole 16a is symmetric, see Fig. 4-5).
Regarding claims 11-12, Bae discloses all the limitations of claim 1. Bae further discloses the modular constraint assembly wherein an outside surface of the constraint member is provided with one or more indicia related to use of the modular constraint assembly, wherein the one or more indicia comprises one or more of: a numeric medication flow rate corresponding to the constraint member, an ordinal identifier of the flow rate corresponding to the constraint member (“The display portion 19 may include a numerical portion 19a indicating a dose and a hue portion 19b corresponding to the numerical portion 19a. Where the numerical portion 19a corresponding to the dose can correspond to the diameter of the through hole 16a of the orifice 16”, [0047] & Fig. 3-6), wherein the one or more indicia further comprises a human readable encoding (display portion 19 is capable of being read by a human, [0047]-[0049] & Fig. 3-6).
Regarding claim 14, Bae discloses all the limitations of claim 1. Bae further discloses the modular constrain assembly wherein an outside surface of the constraint member further comprises a geometric profile, where the geometric profile comprises a shape of a plurality of shapes (display portion 19 comprising a numerical portion 19a and a hue portion 19b, both defining two separate shapes as seen in Fig. 3, also see [0047]; portion 19a, shown in Fig. 6, has a geometric profile in the shape of a rectangle, with square and rectangular sections inside, see Fig. 3-6), and where each shape of the plurality of shapes corresponds to a different dose (“The display portion 19 may include a numerical portion 19a indicating a dose and a hue portion 19b corresponding to the numerical portion 19a. Where the numerical portion 19a corresponding to the dose can correspond to the diameter of the through hole 16a of the orifice 16”, [0047]-[0048] & Fig. 3; “the display unit 19 can be produced for each control dosage set for the drug dose controller 10. In this case, numbers and colors can be displayed together. 6 shows various capacity settings under the condition that the droplet size is 20 drops / ml and the container size is 500 ml.”, [0049] & Fig. 6; each square of the plurality of squares corresponds to a different dose).
Regarding claim 15, Bae discloses all the limitations of claim 1. Bae further discloses the modular constrain assembly wherein an outside surface of the constraint member further comprises a plurality of colors, where the plurality of colors corresponds to a different dose (display unit 19, on an outside of controller 10, in the form of a sticker, as seen in Fig. 3 and 6, containing multiple colors corresponding to a drug dose, [0049]).
Regarding claim 17, Bae discloses all the limitations of claim 1. Bae further discloses the modular constraint assembly wherein the constraint member comprising the molded, rigid constraint profile comprises no compliance against pressure from the fluid medication (“the drug dose controller 10 is luer lock”, [0029]-[0031] & Fig. 4-5; body portion 11 is inherently made of a rigid material which would provide no compliance against pressure from a fluid medication).
Regarding claim 18, Bae discloses all the limitations of claim 1. Bae further discloses the modular constraint assembly wherein the constraint member comprising the molded, rigid constraint profile comprises smoothed internal features (controller 10 comprises internal features, such as inner wall 16c and 16e, which are flat, or smoothed, surfaces, see [0050] & fig. 4-5).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bae (KR 20170041393 A) as applied to claim 4 above, and further in view of Wilson (US 5916201 A).
Regarding claim 10, Bae discloses all the limitations of claim 4. However, Bae fails to explicitly disclose the modular constraint assembly further comprising a clamping feature slidable between two positions, where the clamping feature is configured to either fully stop fluid flow in a first position or allow fluid flow in a second position.
However, Wilson teaches a modular constraint assembly (slide clamp 24 and roll-type clamp 25 can be interpreted as a modular constraint assembly of solution set 10, Col 3 second paragraph & Fig. 1) further comprising a clamping feature slidable between two positions, where the clamping feature is configured to fully stop fluid flow in a first position (slide clamp 24 capable of sliding into a pinch position in which flow is fully stopped, Col 3 second paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Bae with Wilson to include a clamping feature slidable between two positions, where the clamping feature is configured to fully stop fluid flow in a first position, since such a modification would allow a user to completely shut off flow (Col 3 lines 36-41) in case of assembly failure or other device operational error.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bae (KR 20170041393 A), as applied to claim 1 above, and further in view of Abal (US 20120179142 A1).
Regarding claim 13, Bae discloses all the limitations of claim 11. However, Bae fails to explicitly disclose the modular constraint assembly wherein the one or more indicia further comprises a near-field communication or radiofrequency identification chip.
However, Abal teaches a modular constraint assembly (infusion tubing fitment 150, [0019] & Fig. 2) wherein an outside surface of the constraint member is provided with one or more indicia (identification mechanism 710A, tag 710B, bar code 710C, are all example of indicia provided on an outer surface of fitment 150, “It is appreciated that one or more or these or other identification mechanisms 710 may be employed independently or in combination.”, [0037] & Fig. 6-7B; “In one embodiment, such a unique identifier of an identification mechanism 710 can be used for auditing stock, or otherwise keeping track of IV infusion tubing fitment(s) 150 or IV infusion set(s) 100 in which IV infusion tubing fitment 150 is included.”, [0037] and see [0038]) wherein the one or more indicia further comprises a radiofrequency identification chip (RFID tag 710b, [0037] & Fig. 7B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Bae with Abal to include the one or more indicia comprising a radiofrequency identification chip since such a modification would allow a user to keep track of the modular constraint assembly and/or the infusion set to be used with it and distinguish between modular constraint assemblies used for specific treatment, as well as provide means for identification between multiple modular constraint assemblies (see [0037]-[0038] of Abal).
Response to Arguments
Applicant's arguments filed 5/4/2026 have been fully considered but they are not persuasive. In response to Applicant’s arguments that Bae fails to teach a geometric profile, where the geometric profile comprises a shape of a plurality of shapes, the Examiner finds that the numerical potion 19a (Fig. 3-6 of Bae) comprises rectangles and squares, with each square corresponding to a different dose ([0047]-[0049] of Bae).
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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